Evaluation of risk management in a natalizumab home infusion procedure.

Natalizumab is a well-established disease-modifying therapy used in active multiple sclerosis (MS). The most serious adverse event is progressive multifocal leukoencephalopathy. For safety reasons, hospital implementation is mandatory. The SARS-CoV-2 pandemic has deeply affected hospital practices leading French authorities to temporarily authorize to administer the treatment at home. The safety of natalizumab home administration should be assessed to allow ongoing home infusion. The aim of the study is to describe the procedure and assess the safety in a home infusion natalizumab model. Patients presenting relapsing-remitting MS treated by natalizumab for over two years, non-exposed to John Cunningham Virus (JCV) and living in the Lille area (France) were included from July 2020 to February 2021 to receive natalizumab infusion at home every four weeks for 12 months. Teleconsultation occurrence, infusion occurrence, infusion cancelling, JCV risk management, annual MRI completion were analyzed. The number of teleconsultations allowing infusion was 365 (37 patients included in the analysis), all home infusions were preceded by a teleconsultation. Nine patients did not complete the one-year home infusion follow-up. Two teleconsultations canceled infusions. Two teleconsultations led to a hospital visit to assess a potential relapse. No severe adverse event was reported. All 28 patients who have completed the follow-up benefited from biannual hospital examination and JCV serologies and annual MRI. Our results suggested that the established home natalizumab procedure was safe using the university hospital home-care department. However, the procedure should be evaluated using home-based services outside the university hospital.

Investigation of low 5-year relative survival for breast cancer in a London cancer network.

BACKGROUND: Breast cancer 5-year relative survival is low in the North East London Cancer Network (NELCN). METHODS: We compared breast cancer that was diagnosed during 2001-2005 with that in the rest of London. RESULTS: North East London Cancer Network women more often lived in socioeconomic quintile 5 (42 vs 21%) and presented with advanced disease (11 vs 7%). Cox regression analysis showed the survival difference (hazard ratio: 1.27, 95% confidence interval (CI): 1.15-1.41) reduced to 1.00 (95% CI: 0.89-1.11) after adjustment for age, stage, socioeconomic deprivation, ethnicity and treatment. Major drivers were stage and deprivation. Excess mortality was in the first year. CONCLUSION: Late diagnosis occurs in NELCN.

[Medicoeconomic assessment of epilepsy surgery in adults with medically intractable partial epilepsy. Three-year outcomes from a multicenter French cohort]. / Evaluation médicoéconomique de la chirurgie des épilepsies partielles pharmacorésistantes de l'adulte. Résultats à trois ans d'une étude prospective multicentrique française.

PURPOSE: To compare resective surgery and medical therapy in a cost-effectiveness analysis in a multicenter cohort of adult patients with partial intractable epilepsy. POPULATION AND METHODS: Adult patients with partial, medically intractable, potentially operable epilepsy were eligible and followed every year over five years. Effectiveness was defined as one year without seizure. The long-term costs and effectiveness were extrapolated over the patients' lifetime with a Markov model. Productivity (indirect costs) and quality of life (QOLIE-31, SEALS) were also assessed. Changes before and after surgery were compared between the two groups. RESULTS: Two hundred and eighty-nine patients were included (119 with surgery, 161 medically treated, six not eligible, three lost to follow-up). One year after surgery, 81% of the patients were seizure-free; at two and three years, this rate was 78%. In the medical group, these rates were 10, 18, and 15%, respectively. The cost of the explorations was euro 8464; including surgery, it was euro 19,700. In the medical group, the average annual direct costs were between 3500 and euro 6000. At two years after surgery, the annual direct cost decreased to euro 2768, at three years, it was euro 1233, predominately antiepileptic drug costs. Surgery became cost-effective between seven and eight years. In the surgical group, all the quality-of-life scores improved at one year after surgery and were stable during the second and third years. CONCLUSION: Surgical therapy was cost-effective at the middle term even though indirect costs were not considered.

[Cost-effectiveness of epilepsy surgery in a cohort of patients with medically intractable partial epilepsy--preliminary results]. / Evaluation médico-économique de la chirurgie des épilepsies partielles pharmaco-résistantes de l'adulte. Etude coût-efficacité--résultats préliminaires.

OBJECTIVE: Patients with medically intractable epilepsy are potential candidates for surgery if the epileptogenic tissue is localized and resectable. Surgical therapy can eliminate seizures but is very expensive. We followed a prospective adult cohort of intractable epileptic patients in order to perform a cost-effectiveness analysis. POPULATION AND METHODS: Adult patients with a suspected partial medically intractable and operable epilepsy were eligible for evaluation, explorations and/or surgery. Clinical and economical data were collected at the inclusion and every 6 months over at least two years. Two patient groups were analyzed: some underwent a surgery, others did not. Clinical data were compared between both groups. As the data collection was not yet complete, we compared the surgery to a continuation of the preoperative medical management in a cost-effectiveness analysis. Direct medical and nonmedical costs were evaluated according to a societal perspective. The effectiveness was defined as one year without seizure. We assessed the incremental cost-effectiveness ratio (ICER) for the first two years after the surgery. We also modeled long-term costs and effectiveness and extrapolated the results over the patients' lifetime with a Markov model. We computed the ICER and performed a sensitivity analysis. Indirect costs were measured in physical units and intangible costs were assessed with quality-of-life measures (QOLIE-31, SEALS). Data were compared before and after surgery. RESULTS: Among the 286 patients included, 119 did not enter in the analysis: 7 were not eligible, 44 not operable, 31 did not present a follow-up, 37 still underwent exams. Finally, 89 underwent a surgical treatment, and 78 were medically treated. Disease was more severe in surgical patients than in medical patients: seizures frequency, depressive disorders and cognitive impairment were greater. One year after the surgery, 83% patients were seizure free. During the year before inclusion and the year after surgery, direct costs were mainly due to hospitalization. During the second year after surgery, the cost of antiepileptic drugs predominated. One additional year without seizure costs 23 531 euro one year after surgery and 9533 euro two years after surgery. In a long-term perspective, the surgery became cost-effective between 7 and 8 years after the surgery. CONCLUSION: Surgical therapy is a cost-effective treatment in a middle-term even without indirect costs consideration.

Management of diabetes in French prisons: a cross-sectional study.

AIMS: To assess by a survey the management of prisoners with diabetes treated with insulin in French prisons. METHODS: A questionnaire was sent to the head of healthcare services for prisoners of every French prison. Information was obtained on prevalence of insulin-treated diabetes prisoners and diabetes care in prison. The number of episides of ketoacidosis and hypoglycaemia needing hospital admissions were evaluated during the past year. RESULTS: Among the 163 questionnaires sent, 115 were returned, giving an overall response rate of 69%. At the time of the study the prison population was 38 175 people. One hundred and sixty-nine prisoners were treated by insulin (0.4%). Self-monitoring of blood glucose was available only for 94 (55.6%) insulin-treated prisoners. A total of 130 (76.9%) prisoners performed two insulin injections daily or less, 105 (62.1%) prisoners were not allowed to keep their insulin delivery systems with them. Of the prisoners who treated themselves, 14 (12.1%) used syringes and 42 (36.5%) used pen devices. Ninety-two (55.1%) prisoners had had access to a diabetes specialist during the previous year. Diabetic diets were available in only 65 (60.7%) prisons. From June 1998 to June 1999, there were 20 hospital admissions for a diabetic ketoacidosis and 14 for hypoglycaemia. CONCLUSIONS: This study shows that prison decreases the autonomy of diabetic prisoners who often cannot self-inject or test their blood. Access to visiting consultant diabetologists and specialist nurses to educate both prisoners with diabetes and prison staff could improve diabetic care.

High prevalence of hepatitis C virus infection in Belgian intravenous drug users and potential role of the "cotton-filter" in transmission: the GEMT Study.

AIMS: To estimate viral seroprevalences for HCV, HBV and HIV among belgian intravenous (IVDU) and non intravenous (non-IVDU) drug users; to assess risk factors for HCV infection in IVDU; to assess feasibility of chronic hepatitis C follow-up in this population. DESIGN: Cross-sectional study. Demographic and behavioural characteristics were obtained by a standardized questionnaire. Serum samples were tested for HCV, HBV and HIV. SUBJECTS AND SETTING: 329 patients (244 IVDU and 85 non-IVDU) attending ten general practitioners in 1995. RESULTS: HCV seroprevalence was 78.3%; it was 35.7% for HBV and 0.9% for HIV in IVDU, vs 2.4%, 8.3% and 0%, respectively, in non-IVDU. In logistic regression analysis, independent risk factors for HCV infection were: 1/sharing of syringes and/or of "cottons" used as filters (adjusted prevalence odds ratio [POR] = 31.7; 95% confidence interval [CI] = 9.8-102.5), 2/duration of injecting upper than one month (adjusted POR = 8.6; CI = 3.0-24.7) and 3/age (adjusted POR = 1.2 by year of difference; CI = 1.0-1.3). A biochemical follow-up was obtained in 70% of HCV seropositive users; 79.5% of them had chronic hepatitis C (mean value of ALT = 3.5 times upper normal value, range 1.1-23.0). Among these, 24.7% went through liver biopsy during the three years follow-up period of the study. CONCLUSIONS: HCV seroprevalence is very high among belgian IVDU. Prevention strategies have to focus on neophytes injectors. They must be urgently revisited for what concern needles/syringes exchange programs: "cottons" must be included. Follow-up and treatment of chronic hepatitis C seem to be poorly effective among drug users.

[History of a wholesaler: CERP-Rouen]. / Histoire d'un grossiste-repartiteur: la CERP-Rouen.

MCPR (Mutuelle cooperative pharmaceutique rouennaise) was created in November 1919 and furnished specialities to pharmacists in Haute-Normandie. It moved to various places and finally was situated in 1939 rue des Augustins, where its central office is still nowadays. During World-War II, many difficulties occurred: fire in 1940, bombing in 1944, great lack of possibilities. After peace, it took benefit of the great increase of its market. It worked for the grouping of wholesalers companies and became in 1965 CERP-Rouen. It strenghtened its internal growth by creating new sites and introducing new techniques: teletransmission computer networks, officinal PC. Since 1969 to 1986, nine wholesalers were partially or totally incorporated in the group and CERP got to a national position: 34 agencies, 6,000 members, 1010 FF. Since 1986, it reached the European level (Belgium, Spain, Poland) and overseas departments (Martinique-Guyane).

[Percutaneous closure of patent ductus arteriosus: results and costs compared to surgical closure]. / Fermeture du canal artériel par voie percutanée: comparaison des résultats et des coûts avec la fermeture chirurgicale.

The comparison of the clinical results and costs of the two methods of closure of patient ductus arteriosus was undertaken in two comparable groups of 40 patients treated in the same period in the same hospital. After transcatheter closure there was a 9% residual shunt rate at 3 years, the 2 patients with a residual continuous murmur being operated secondarily. The only complication was severe haemolysis which regressed after transcatheter ablation of the prosthesis. After surgical closure, there were no residual shunt. Some postoperative complications were observed in 20% of cases, usually benign (ventilatory problems, dysphonia or urinary infection), but occasionally more serious (peroperative lesion of the pulmonary artery). Morbidity, inherent to the technique of closure, was very different and much less in catheter closure. The average cost (daily cost x average length of hospital stay) was much less with transcatheter closure 38,558 francs versus 11,240 francs. On the other hand, the direct cost of transcatheter closure was greater than that of surgery: 32,798 francs versus 20,903 francs, the difference being related to the actual price of the prosthesis. The authors conclude that the 3 year results of transcatheter closure of patent ductus arterious make this technique a reasonable therapeutic alternative to surgery. From the safety point of view, the two techniques are comparable bu patient confort is greater with transcatheter closure for an increase in cost of the initial procedure which should decrease in relation to the types and prices of the prosthesis used.

Assessment of fluorochromes for cellular structure and function studies by flow cytometry.

Because flow cytometry permits the analysis of individual whole cells, one of the key requirements in selecting a probe is its ability to target the site of interest into cells. In addition, dyes must possess ideal properties (ie extinction coefficient, Stoke's shift) rendering them appropriate for this methodology. Other characteristics, such as fluorescence quenching and energy transfer, inherent to the staining, provide numerous applications in flow cytometry. The available fluorophores used in flow cytometry are classified according to their cellular incorporation and binding. Thus, probes are presented and discussed as follows: 1) dyes of cellular components (DNA, RNA, proteins, lipids); 2) probes of membrane potential; 3) fluorophores that are sensitive to their microenvironment (pH, calcium, etc); and 4) those used for measurement of enzymatic activities into cells.

Experience with a community screening program for hypertension: results on 24,462 individuals.

A hypertension screening program was conducted by means of mobile units generally used for detection of tuberculosis and chest diseases. From 1st October 1973 to 31st July 1976, 24, 462 individuals aged 35 and over were examined. 10.7% were found to have elevated blood pressure (greater than 160/95 mm Hg). Among these subjects, 43% of the male and 24% of the female had never been told they were hypertensive. 5.6% of the men and 7% of the women had a diastolic reading of 105 mm Hg or more. Undetected hypertension decreased with age and was less frequent in women than in men. Young male hypertensives were frequently aware of their disease. When known, hypertension remained untreated in 14.5% of cases and badly controlled in 26%. One yr after screening, 400 patients who had been found to have undetected hypertension were contacted; 358 (89.5%) had seen their family doctor and 42% of them were under continuous medical treatment. These results further underline the challenge of undetected, untreated and uncontrolled hypertension.