Postsurgery analgesic and sedative drug use in a French neonatal intensive care unit: A single-center retrospective cohort study.

OBJECTIVE: To describe pain assessment, the pattern of analgesic and sedative drug use, and adverse drug reactions in a neonatal intensive care unit (NICU) during the postsurgery phase. METHOD: Demographic characteristics, pain scores, and drug use were extracted and analyzed from electronic patient medical files for infants after surgery, admitted consecutively between January 2012 and June 2013. RESULT: One hundred and sixty-eight infants were included. Acute (DAN score) and prolonged (EDIN score) pain assessment scores were used in 79% and 64% of infants, respectively, on the 1st day. This percentage decreased over the 7 days following surgery. The weekly average scores postsurgery were 2/15 (±2.2) for the EDIN score and 1.6/10 (±2.0) for the DAN score. The rates of pain control were 88% for the EDIN and 72% for the DAN. The most prescribed opiate drug was fentanyl (98 patients; 58%) with an average dose of 1.8 (±0.6) µg/kg/h. Midazolam was used in 95 patients (56%), with an average dose of 35 (±14) µg/kg/h. A bolus was administered in 7% (±7.4) of the total dose for fentanyl and 8% (±9.3) for midazolam. Similar doses were used in term and preterm neonates. Of 118 patients receiving fentanyl and/or midazolam, 40% presented urinary retention, 28% a weaning syndrome. Paracetamol (155 patients; 92%) and nalbuphine (55 patients; 33%) were the other medications most often prescribed. CONCLUSION: The off-label use of fentanyl and midazolam was necessary to treat pain after surgery. Pain assessment should be conducted for all neonates in order to optimize their treatment. Research on analgesic and sedative medicine in vulnerable neonates seems necessary to standardize practices and reduce adverse drug reactions.

[Management of post-traumatic aphakia and aniridia: Retrospective study of 17 patients undergoing scleral-sutured artificial iris intraocular lens implantation. Management of aphakia-aniridia with scleral-sutured artificial iris intraocular lenses]. / Prise en charge de l'aphakie et de l'aniridie post-traumatiques. Étude rétrospective de 17 patients opérés d'implants intraoculaires suturés à la sclère à iris artificiel. Gestion de l'aphakie-aniridie par implants suturés à la sclère à iris artificiel.

PURPOSE: To evaluate the long-term outcomes of artificial iris intraocular lenses sutured to the sclera for managing traumatic aphakia and aniridia. METHODS: All consecutive cases receiving a Morcher® combination implant from June 2008 to February 2016 in Edouard-Herriot Hospital (Lyon, France) were included in this single-center retrospective study. Visual acuity, subjective degree of glare, quality of life and surgical complications were evaluated. RESULTS: Seventeen eyes of 17 patients were included, among which 82% were male. The mean age was 42 years. The injuries consisted of 23.5% contusion and 70.5% open globe injuries, of which 41% were globe ruptures. There was one postoperative case. A penetrating keratoplasty was performed at the same time for eight eyes. The mean follow-up was 32 months. Best-corrected visual acuity improved in 41.2%, remained the same in 17.6% and decreased in 41.2% of our cases. Distance vision averaged 1±0.25 line better and near vision 2.2±0.32 lines better when visual acuity was quantifiable before surgery. Glare improved in 80% of patients and remained stable in 20%, decreasing on average from 3.3/5 [min. 3-max. 4; SD: 0.48] before surgery to 1.9/5 [min. 0-max. 4; SD: 1.197] after surgery. Regarding the esthetic results, 78% of the patients declared themselves reasonably to very satisfied; 57% reported no limitation of activities of daily living, and 43% reported mild limitation. Ocular hypertension and glaucoma, found in 40% of eyes, were the main postoperative complications. CONCLUSION: Implantation of prosthetic iris device combined with an intraocular lens appears to be safe and effective in reducing glare disability and improving visual acuity. Close, long-term monitoring is essential for the success of this surgery.

Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children.

BACKGROUND: The aim of the study was to determine whether the introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety levels of children undergoing major surgery. Secondary objectives were to determine whether the level of understanding of participants and other risk factors influence STAIC-S (State-Trait Anxiety Inventory for Children-State subscale) score in children. METHODS: We performed a randomized controlled parallel-group trial comparing preoperative anxiety between two groups of children aged >6 and <17 yr. Before surgery, the intervention group received a comic information leaflet at home in addition to routine information given by the anaesthetist at least 1 day before surgery. The control group received the routine information only. The outcome measure was the difference between STAIC-S scores measured before any intervention and after the anaesthetist's visit. A multiple regression analysis was performed to explore the influence of the level of education, the anxiety of parents, and the childrens' intelligence quotient on STAIC-S scores. RESULTS: One hundred and fifteen children were randomized between April 2009 and April 2013. An intention-to-treat analysis on data from 111 patients showed a significant reduction (P=0.002) in STAIC-S in the intervention group (n=54, mean=-2.2) compared with the control group (n=57, mean=0.90). The multiple regression analysis did not show any influence on STAIC-S scores of the level of education, parental anxiety, or the intelligence quotient of the children. CONCLUSIONS: A paediatric anaesthesia comic information leaflet was a cheap and effective means of reducing preoperative anxiety, measured by STAIC-S, in children. CLINICAL TRIALS REGISTRATION: NCT 00841022.

Reduced bone volumetric density and weak correlation between infection and bone markers in cystic fibrosis adult patients.

UNLABELLED: In our current adult CF population, low BMD prevalence was only 20 %, lower than that historically described. We found a mild increase of serum RANK-L levels, independent from the bone resorption level. The increased fracture risk in CF may be explained by a lower tibial cortical thickness and total vBMD. INTRODUCTION: Bone disease is now well described in cystic fibrosis (CF) adult patients. CF bone disease is multifactorial but many studies suggested the crucial role of inflammation. The objectives of this study were, in a current adult CF population, to assess the prevalence of bone disease, to examine its relationship with infections and inflammation, and to characterize the bone microarchitecture using high resolution peripheral scanner (HR-pQCT). METHODS: Fifty-six patients (52 % men, 26 ± 7 years) were assessed in clinically stable period, during a respiratory infection, and finally 14 days after the end of antibiotic therapy. At each time points, we performed a clinical evaluation, lung function tests, and biochemical tests. Absorptiometry and dorso-lumbar radiographs were also performed. A subgroup of 40 CF patients (63 % men, 29 ± 6 years) underwent bone microarchitecture assessment and was age- and gender-matched with 80 healthy controls. RESULTS: Among the 56 CF patients, the prevalence of low areal BMD (T-score < -2 at any site), was 20 % (95 % CI: [10.2 %; 32.4 %]). After infections, serum RANK-L (+24 %, p = 0.08) and OPG (+13 %, p = 0.04) were increased with a stable ratio. Microarchitectural differences were mostly observed at the distal tibia, with lower total and cortical vBMD and trabecular thickness (respectively -9.9, -3.0, and -5 %, p < 0.05) in CF patients compared to controls, after adjustment for age, gender, weight, and height. CONCLUSIONS: In this study, bone disease among adult CF patients was less severe than that previously described with only 20 % of CF patients with low BMD. We found a mild increase of biological marker levels and an impaired volumetric density of the tibia that may explain the increased fracture risk in CF population.

Value of prostate multiparametric magnetic resonance imaging for predicting biopsy results in first or repeat biopsy.

AIM: To assess multiparametric magnetic resonance imaging (mp-MRI) in predicting prostate biopsy results. MATERIALS AND METHODS: Patients who underwent mp-MRI prior to prostate biopsy were prospectively included. The prostate was subdivided into 14 sectors and mp-MRI findings assessed using a five-level subjective suspicion score (SSS). Biopsy included targeted samples of abnormal sectors and systematic samples of normal peripheral zone sectors. RESULTS: Two hundred and eighty-eight patients were included [153 biopsy naïve, 135 with negative (n = 51) or positive (n = 84) prior biopsy]. Biopsy was positive in 168 patients. mp-MRI area under the receiver operating characteristic (ROC) curve (AUC) was 69.1% (95% CI: 67.1-70.9%), 72.5% (95% CI: 69.5-76%), and 73.8% (95% CI: 68.3-79.3%) at per sector, per lobe, and per patient analysis, respectively. At the per sector level, the AUC was significantly larger if detection was limited to cancers with a Gleason score of ≥7 (72.6%; 95% CI: 69.8-75.8%; p < 0.01) or ≥8 (87.1%; 95% CI: 78.3-95.7%; p < 0.01). mp-MRI performance was significantly influenced by prostate volume (p = 0.02), the presence of a concordant hypoechoic area (p < 0.001), but not by prostate-specific antigen (PSA) value, status of prior biopsy, or radiologists' experience. SSS was significantly associated with the Gleason score in true-positive lobes and patients (p < 0.0001). Using a SSS threshold of ≥3, cancer was missed in 13/102 lobes and 4/72 patients with cancers of Gleason score ≥7. CONCLUSION: mp-MRI provides a good detection of cancers with a Gleason score of ≥7 in candidates suitable for prostate biopsy.

Differentiation of transitional zone prostate cancer from benign hyperplasia nodules: evaluation of discriminant criteria at multiparametric MRI.

AIM: To assess topographical and magnetic resonance imaging (MRI) features in characterizing prostate transitional zone (TZ) nodules. MATERIALS AND METHODS: Two radiologists evaluated all TZ nodules visible at multiparametric MRI in 52 consecutive patients who underwent radical prostatectomy. The radiologists assessed topographical (anteroposterior and superior-inferior location, crossing of the sagittal midline) and T2-weighted (shape, presence and distinctness of capsule, distinctness of contours, presence of cysts) features, the apparent diffusion coefficient (ADC), and eight semi-quantitative and quantitative enhancement parameters derived from dynamic contrast-enhanced (DCE) imaging. The nature of the nodules was assessed using prostatectomy specimens. Five statistical methods taking into account multiple testing were used. RESULTS: One hundred and thirty-seven nodules (117 benign, 20 malignant) were evaluated. Mean ADC, all topographical, and all T2-weighted features were significant predictors of malignancy according to at least four out of the five statistical methods. Particularly, 20/20 and 18/20 cancers involved the anterior and apical third of the TZ, respectively. None of the enhancement parameters was significantly different between cancers and benign nodules. By assessing the presence of cysts, the nodules' capsule, and their anteroposterior and superior-inferior location, 111/117 benign nodules were correctly diagnosed, without misclassifying any cancer. CONCLUSION: Topographical, T2-weighted, and diffusion-weighted features can be used to characterize TZ nodules. DCE imaging does not seem to provide additional information.

Does weight loss predict accuracy of setup in head and neck cancer patients treated with Intensity-Modulated Radiation Therapy?

PURPOSE: This prospective study reports the impact of weight loss on setup of head and neck (H&N) cancer patients treated by Intensity-Modulated Radiation Therapy (IMRT). MATERIALS AND METHODS: Setup errors of H&N cancer patients treated by IMRT from January to June 2010 were prospectively analysed and statistically related to weight loss. A mixed linear model was used for statistical evaluations. Setup margins of our institute were also calculated. RESULTS: Twenty-two patients and 128 pairs of Electronic Portal Images (EPI) were analysed. Setup errors varied between -0.6 and +0.6, -0.7 and +0.8 and -0.2 and +0.8 in the anterior-posterior, superior-inferior and right-left direction, respectively. Median and mean weight loss were 2.1 and 3.1 kg (range 0-12 kg), respectively; median and mean percent of weight loss were 2.95% and 4.64% (range 0.3-19.7%), respectively. No statistical relation was seen between weight loss and the setup errors. CONCLUSIONS: Weight loss is not a good clinical parameters for predicting an increase of setup errors. Other clinical and/or anthropometrical features should be prospectively evaluated in order to assess the need for re-planning.

Robust non-linear mixed modelling of longitudinal PSA levels after prostate cancer treatment.

The objective of this study was to develop a robust non-linear mixed model for prostate-specific antigen (PSA) measurements after a high-intensity focused ultrasound (HIFU) treatment for prostate cancer. The characteristics of these data are the presence of outlying values and non-normal random effects. A numerical study proved that parameter estimates can be biased if these characteristics are not taken into account. The intra-patient variability was described by a Student-t distribution and Dirichlet process priors were assumed for non-normal random effects; a process that limited the bias and provided more efficient parameter estimates than a classical mixed model with normal residuals and random effects. It was applied to the determination of the best dynamic PSA criterion for the diagnosis of prostate cancer recurrence, but could be used in studies that rely on PSA data to improve prognosis or compare treatment efficiencies and also with other longitudinal biomarkers that, such as PSA, present outlying values and non-normal random effects.

[A positioning pillow to improve lumbar puncture in paediatric haematology-oncology patients: a randomized controlled trial.]. / Coussin de positionnement pour ponctions lombaires en oncohématologie pédiatrique : résultats d'un essai randomisé

ObjectivesLumbar punctures (LPs) are common in children with cancer. Although pain management during the LP has been well standardised, dealing with stress and anxiety is not well addressed yet. Our objective was to evaluate the potential improvement of the LPs success rate using a positioning pillow, to ensure maximum lumbar flexion, and allow paravertebral muscles to relax, in children who are awake, with either conscious sedation or no sedation.Patients and methodsChildren aged 2-18 years undergoing LPs were randomly assigned to a positioning pillow or no intervention. The primary outcome was the rate of success, i.e. achieving the LPs (sampling or injection) at the first attempt, without bleeding (RBC < 50/mm3). The secondary outcomes included: the child's pain, assessed by a self-administered visual analogical scales (VAS) for children over 6 years of age; the parents' and caregivers' perception of the child's pain; the satisfaction of the children, the parents, the caregivers and the physician. The child's cooperation and the occurrence of post-LP syndrome were also evaluated.ResultsOne hundred twenty-four children (62 in each group) were included. The LP pillow tended to increase the success rate of LPs (67 vs 57%; P = 0.23), and decreased the post-LP syndromes (15 vs 24%; P = 0.17) but the differences were not statistically significant. In children over 6-year of age (N = 72), the rate of success was significantly higher in the pillow group (58.5 vs 41.5%; P = 0.031), with a tendency to feel less pain (for less pain and better satisfaction) [median VAS: 25 vs 15 mm; P = 0.39] and being more satisfied (84.4 vs 75.0%; P = 0.34).ConclusionEven if the results presented here are not as optimistic as we might have wished, we can confirm that there is a benefit in using this pillow for LPs. It is especially promising in children over 6-year of age.

[Endoscopy versus microsurgery: results in a consecutive series of nonfunctioning pituitary adenomas]. / Résultats comparés de la chirurgie endoscopique et de la microchirurgie dans une série consécutive de macroadénomes hypophysaires non fonctionnels.

Microsurgical removal of nonfunctioning pituitary adenomas (NFPAs) is often subtotal. Removing the blind spots as viewed through the microscope, endoscopic surgery may improve the quality of removal. Our purpose was to compare the results of the two techniques in a series of NFPA patients operated on by a single surgeon. Thirty-six patients with newly diagnosed NFPAs were operated on using a purely endoscopic procedure and 29 with a microsurgical technique. All patients were explored pre- and postoperatively (at 3 and 6 months and then every 12 months) by endocrine assays, ophthalmologic exam, and 3D MRI. The endocrine and ophthalmologic results as well as the quality of resection and the complications from the two techniques were compared. The follow-up duration and the mean tumor volume (higher in the microsurgical group) were the only differences observed between the two groups. Tumor height and the invasion of the cavernous sinus were not different. All patients with preoperative visual impairment in the endoscopic group improved, whereas in the microsurgical group 90.9% improved, 4.5% were stabilized, and 4.5% worsened (p=ns). Regarding anterior pituitary functions, 42.8% of the patients improved in the endoscopic group, 45.7% remained stable, and 11.4% worsened compared to, respectively, 31, 44,8, and 24.1% in the microsurgical group (p=ns). Gross total removal was achieved in 86.1% for the endoscopic group and in only 65.5% for the microsurgical group (p=0.075). Morbidity was similar in the two groups. This retrospective series showed that endoscopic surgery compared to microsurgery increases the quality of NFPA removal with similar morbidity.

Blood pressure drop and symptoms during ATP-test under pacing.

We studied systolic blood pressure (SBP) behavior and symptoms during ATP-test in temporary paced patients. SBP drop during ATP-test is only partially prevented by pacing. During DDD paced ATP-test, SBP minimum was lower in symptomatic patients. Considering the role of endogenous adenosine in neurally-mediated syncope (NMS), our results are concurrent with a SBP fall resulting in NMS recurrence under permanent pacing.

[Locally recurrent prostatic adenocarcinoma after exclusive radiotherapy: results of high intensity focused ultrasound]. / Adénocarcinome prostatique en récidive locale après radiothérapie exclusive: résultats du traitement par ultrasons focalisés.

OBJECTIVES: To determine the efficacy and adverse effects of high intensity focused ultrasound (HIFU) for the treatment of local recurrence of prostate cancer after exclusive external beam radiotherapy. MATERIAL AND METHODS: Seventy-two patients with histologically and biologically documented local recurrence after radiotherapy were treated by HIFU. The mean age was 68.27+/-5.93 years, and mean PSA was 6.64+/-7.26ng/ml. Thirty patients were treated according to standard parameters and 42 according to specific parameters. ASTRO 2005 criteria, specific for salvage therapy (Phoenix consensus), were used to define recurrence. Progression-free survival was calculated by the Kaplan-Meier method. RESULTS: Mean follow-up was 39+/-28 months. The negative biopsy rate was 80% and the median nadir PSA was 0.10ng/ml. Specific survival was 94% at three years and 90% at five years, and progression-free survival was 50% at three years and 44% at five years. The urinary incontinence rate was 44% (grade 1 : 12%, grade 2/3 : 32%) and the urethral stricture or bladder neck stenosis rate was 30%. The use of specific parameters reduced the incidence of severe incontinence (19% versus 50, P=0.005) and stenosis (24% versus 40). CONCLUSIONS: Treatment with HIFU achieved a five-year progression-free survival of 44%, but patients must be clearly informed about the high rate of adverse effects.

Influence of intraocular lens material on the development of acute endophthalmitis after cataract surgery?

PURPOSE: To investigate the causal relationship between acute postoperative endophthalmitis (POE) after cataract surgery and the biomaterial properties of the intraocular lens (IOLs) implanted. METHODS: This retrospective cohort study included all patients who had undergone cataract surgery with IOL implantation at the Lyon Croix-Rousse University Hospital between 1st January 1994 and 31st December 2004. Details respecting the type of IOL implanted (material and manufacturer) were meticulously recorded. The number of patients presenting with POE within 6 weeks of cataract surgery was documented together with their medical characteristics. These data were then compared, and Fisher's exact test was used to establish the significance of any apparent associations. RESULTS: Eight of the 5837 eyes manifested acute POE (0.14%). Seven of these were composed of polymethylmethacrylate (PMMA) and one of heparinized PMMA. Patients with PMMA IOLs carried a higher risk of developing POE than did those implanted with either heparinized PMMA (P=0.001), hydrophilic acrylic, or hydrophobic acrylic IOLs (P=0.002). CONCLUSIONS: The incidence of acute POE after cataract surgery in our hospital is similar to that currently reported for other institutions in developed countries. Our results add further evidence that IOL material and type are factors contributing to the risk to develop an acute POE after cataract surgery, and that PMMA IOLs may be associated with an increased risk of POE.

Effects of residential distance to hospitals with neonatal surgery care on prenatal management and outcome of pregnancies with severe fetal malformations.

OBJECTIVES: To examine the effect of maternal origin and distance between maternal residence and the nearest maternity ward with a neonatal surgical center in the same hospital, on prenatal diagnosis, elective termination of pregnancy, delivery in an adequate place and neonatal mortality for pregnancies with severe malformations requiring neonatal surgery, and to examine the effect of the place of delivery on neonatal mortality. METHODS: This was a retrospective study, through the France Central-East malformation registry, of 706 fetuses with omphalocele (n = 123), gastroschisis (n = 99), diaphragmatic hernia (n = 222), or spina bifida (n = 262), but without chromosomal anomalies. Maternal origin was classified as Western European and non-Western European. Adequate place for delivery was defined as birth in a Level-III maternity ward with a neonatal surgical center in the same hospital. RESULTS: The prenatal diagnosis rate was 67.7% in 1990-1995 and 80.2% in 1996-2001 (odds ratio (OR), 2.07 (95% CI, 1.24-3.45)). On multivariate analysis, the rate was significantly lower for women living 11-50 km (adjusted OR, 0.49 (95% CI, 0.25-0.94)), or > 50 km (adjusted OR, 0.39 (0.20-0.74)) from the closest adequate place of delivery, compared with those living < 11 km from it, but there was no difference for maternal origin. Non-Western European women had fewer elective terminations of pregnancy (adjusted OR, 0.34 (95% CI, 0.14-0.81)) and fewer deliveries in an adequate place (adjusted OR, 0.40 (95% CI, 0.18-0.89)). Neonatal mortality was lower in the case of delivery in an adequate place (adjusted OR, 0.22 (95% CI, 0.07-0.72)) and was not associated with maternal origin and distance from nearest maternity ward with a neonatal surgical center. CONCLUSION: Rate of prenatal diagnosis decreases with increasing distance between parental residence and referral center. Non-Western European women are diagnosed prenatally as often as are Western Europeans, but terminate their pregnancy less often, perhaps for cultural reasons. Non-Western European women with malformed fetuses deliver in adequate centers less often, probably because of the way the perinatal care system is run.

[Long-term efficiency of vagus nerve stimulation (VNS) in non-surgical refractory epilepsies in adolescents and adults]. / Efficacité de la stimulation intermittente du nerf vague dans les épilepsies pharmaco-résistantes non chirurgicales de l'adolescent et de l'adulte.

Vagus Nerve Stimulation (VNS) is recognized as an efficient procedure for controlling seizures in patients with drug-refractory epilepsies. It is used as a palliative procedure as a complement to conventional treatment by antiepileptic (AE) drugs and, according to literature, 40 to 50p.cent of patients report a decrease in seizures frequency >or=50p.cent, which is usually accepted to classify patients as responders in add on AE drug trials. The objectives of this study based on retrospective analysis of 50 consecutive patients with partial (39) or generalized (11) refractory epilepsy non eligible for surgery were; firstly to evaluate the global long term VNS efficacy and secondly to identify potential predictors of the VNS effects on seizure frequency. No patient has been seizure free at any moment of the follow up (2.8+/-1.8 years, max: 6 years) and the AE has been maintained in all. During follow up 44, 66, 61 and 58p.cent of patients were classified as responders at 6 months, 1, 2 and 3 years, respectively. Logistic regression analysis showed that: the percentage of responders at 6 months of follow up and later was significantly higher than that before 6 months (p=0.002); generalized epilepsy was predictive of a better outcome as compared to partial epilepsy (p=0.03); there was a trend for a better outcome in partial epilepsies symptomatic of a focal lesion than in those with normal brain MRI (p=0.06). These results are in line with previously published data in terms of global efficiency and confirm that seizures control does not reach its maximal level before at least one year of VNS. In severe generalized epilepsies (either secondary or cryptogenic) manifesting by frequent falls due to atonic or tonic-clonic generalized seizures VNS is a useful palliative procedure, which entails much les of surgical risk than callosotomy. The better VNS effects in patients with partial epilepsy possibly reflect the high incidence in our series of Malformations of Cortical Development, which have been identified as one the few variables possibly predictive of a response over 50p.cent of seizures frequency reduction.

[Sensitivity and specificity of two methods used to identify incident breast cancer in specialized units using claims databases]. / Sensibilité et spécificité de deux méthodes d'identification des cancers du sein incidents dans les services spécialisés à partir des données médico-administratives.

BACKGROUND: Hospital claims databases from acute care units are available nationwide and contain most patients at the beginning of their cancer. The goal is to define the ability of these databases to provide a number of incident breast cancer cases using identification methods. Two identification methods were assessed in three specialized sections of a teaching hospital. METHODS: The first method identified women who had at least one stay with a principal diagnosis of breast cancer. The second, which is more restrictive, identified women who had at least one stay with a principal diagnosis of breast cancer and a breast cancer-specific surgical treatment code. Both methods were applied to 4588 women 20 Years of age or older hospitalized in three specialized sections of the Hospices Civils de Lyon in 2000. To categorize these women in two groups, incident breast cancer cases or non-incident breast cancer cases, 150 women were randomized in each of two groups, one for incident breast cancer cases and one for non-incident breast cancer cases. Their medical records were used as references. RESULTS: Sensitivity, specificity and their credibility intervals were respectively 99.4% (84-99.9) and 91.7% (90.3-93.3) for the first method and 93.8% (76.2-98.7) and 97.3% (96.1-98) for the second. Among women wrongly identified with an incident breast cancer in 2000, 75.4% (43/57) had a breast cancer that was not incident that Year with the first method, compared to 96% (24/25) with the second. Among these women wrongly identified with an incident breast cancer, coding errors of the principal diagnosis were found for 24.6% (14/57) of patients with the first method and for 4% (1/25) with the second. Their correction led to 99.2% (86.5-99.9) sensitivity and 92.9% (91.4-94.6) specificity for the first method and to 94.2% (76.5-98.7) sensitivity and 97.3% (96.2-98.1) specificity for the second. CONCLUSIONS: The second method using cancer-specific surgical codes appeared more specific with a slight loss in sensitivity. The use of identification methods to assess the number of incident cancer cases still have to be defined.

Method of correction to assess the number of hospitalized incident breast cancer cases based on claims databases.

Estimations of the number of hospitalized incident cancer cases show biases when claims databases are used. This is due to false reports of incident cancer because of a lack of specificity, and because of unrecorded cancers resulting from a lack of sensitivity. We present a statistical method to provide corrected estimations. This method is based on a two-phase study design using an external data set for sensitivity and specificity estimates. Inaccuracy of the corrected number of hospitalized incident cancer cases was assessed by a credibility interval determined by a Bayesian approach using a Monte Carlo method. Based on the population hospitalized in a large group of French University hospitals, 334 women were identified in the French claims database as having potential incident cases of breast cancer in 1997. According to our method, the corrected number was 565 (550-580). In absence of hospital-based cancer registries, our approach provides estimates and credibility intervals, and has many potential applications in defining hospital policies with its applicability to other diseases.

Thrombolysis in myocardial infarction in a prospective cohort of 2,515 consecutive patients: older age and longer delays lead to a lower thrombolysis rate.

OBJECTIVE: This prospective study sought to determine the rate of thrombolysis in myocardial infarction and the factors that influenced it in everyday practice. METHODS AND RESULTS: Data were prospectively collected in all patients admitted in all (48) university, community, and private hospitals in three departments in the Rhjne-Alpes region in France between September 1, 1993 and January 31, 1995. Data from 2,515 patients were included. Overall, 36% of the patients received thrombolysis. The decrease of the thrombolysis rate with age was very regular. The difference between men and women disappeared almost completely when age was taken into account in a bivariate analysis. Among 19 variables introduced in the logistic regression, only the following ones were significant predictors (odds ratio < 1 means less thrombolysis): age (odds ratio: 0.60 per decade), administrative department, type of hospital (community/tertiary: 0.74; private/tertiary: 0.58), history of myocardial infarction or of angina pectoris (0.67), location of myocardial infarction (Q wave non anterior/Q wave anterior: 0.75; non Q wave/Q wave anterior: 0.18), delay between symptoms onset and first medical intervention (0.06), history of cancer (0.47), and history of psychiatric disorder (0.38). CONCLUSIONS: In France as in other countries, the rate of thrombolysis is low. In order to increase this rate, we have to find ways to be more "aggressive" in older patients, and to precisely describe the health care pathways in order to shorten delays.

Chronological aspects of ultrasonic, hormonal, and other indirect indices of ovulation.

OBJECTIVE: To improve prediction of ovulation in normal cycles. DESIGN: Collection of women's characteristics and their menstrual cycles. Monitoring and analysis of time relationships between several indicators of ovulation: transvaginal ultrasonography, cervical mucus, basal body temperature, urinary luteinising hormone, and ratio of urinary oestrogen to progesterone metabolites. SETTING: Each of eight natural family planning clinics was to study 12 women for at least three cycles. POPULATION: One hundred and seven normally fertile and cycling women aged 18 to 45. METHODS: Daily measurements of urinary luteinising hormone, follicle stimulating hormone, oestrone-3-glucuronide and pregnanediol-3alpha-glucuronide. Basal body temperature recording and cervical mucus checking. Transvaginal ultrasound examination of the ovaries. MAIN OUTCOME MEASURES: Delays between the expected day of ovulation according to the luteinising hormone peak or to ultrasound evidence and the expected days according to the other indices of ovulation. RESULTS: Ultrasonography was able to show evidence of ovulation in 283 out of 326 cycles. The average time lag between luteinising hormone peak and ultrasound evidence was less than one day (+0.46) but premature and late luteinising hormone-expected date of ovulation were observed in nearly 10% and 23% of cycles, respectively. Basal body temperature rise was observed in 98% of cycles. Cervical mucus peak symptom, rapid drop in the ratio of urinary metabolites, and luteinising hormone initial rise were all close to ultrasonographic evidence in more than 72% of cycles. CONCLUSIONS: For accuracy and practical reasons, the cervical mucus peak symptom, the ratio of urinary metabolites and luteinising hormone initial rise might be better indices of ovulation than the luteinising hormone peak.

Gonadotropin level abnormalities in women with cyclic mastalgia.

OBJECTIVES: Women with cyclic mastalgia seem to be at risk of fibrocystic breast disease and/or breast cancer. We studied the relationships between mastalgia and hormone levels throughout the menstrual cycle. STUDY DESIGN: Ostensibly healthy women were monitored during a sum of 326 cycles. A case-control study compared personal and hormonal variables of 30 women experiencing cyclic mastalgia with those of 77 women without this symptom. RESULTS: Except sleeping times, no significant differences were found in personal variables. Cyclic mastalgia and symptoms of fluid retention were slightly associated. Menses and the luteal phase were significantly longer in cases than in controls. Gonadotropin but not ovarian hormone levels were also significantly higher in cases throughout the cycle. CONCLUSION: Cyclic mastalgia is less related to symptoms of fluid retention or to ovarian hormone levels than to regularly high gonadotropin levels, specific inhibitors might thus be used to alleviate the symptom.