OPHDIAT: a telemedical network screening system for diabetic retinopathy in the Ile-de-France.

OBJECTIVE: International and national guidelines recommend an annual funduscopic examination for all diabetic patients, but such annual fundus examinations are not sufficiently performed in France. Non-mydriatic fundus photography is a valid method of evaluation for diabetic retinopathy (DR) and a viable alternative to ophthalmoscopy. After two pilot studies demonstrated the feasibility of telemedical screening for diabetic retinopathy in both hospital and primary-care settings, we developed a regional telemedical network, OPHDIAT, designed to facilitate access to regular annual evaluations of patients with diabetes while saving medical time. MATERIALS AND METHODS: OPHDIAT comprises peripheral screening centres equipped with non-mydriatic cameras, where fundus photographs are taken by technicians linked by telemedicine to a reference centre, where ophthalmologists grade the images. Currently in the Ile-de-France region, 16 screening centres are linked through a central server to an ophthalmologic reading centre and includes 11 centres located in the diabetes departments of 11 hospitals, one diabetic retinopathy screening centre located in northern Paris, three in healthcare centres and one in a prison. RESULTS: During the 28-month evaluation period, 15,307 DR screening examinations were performed. Retinal photographs of at least one eye could not be graded in 1332 patients (9.7%) and diabetic retinopathy was detected in 3350 patients (23.4%). After the screening examination, 3478 patients (25.2%) were referred to an ophthalmologist for either DR, cataract and/or non-gradable photographs. CONCLUSION: Fundus photography combined with telemedicine has the potential to improve the regular annual evaluation for diabetic retinopathy. The organization of the network around a central reading centre serves to guarantee quality control.

OPHDIAT: quality-assurance programme plan and performance of the network.

AIMS: There is a need for evaluation of screening and grading services for diabetic retinopathy (DR) in compliance with quality-assurance (QA) standards. We describe the screening/grading QA programme set up for OPHDIAT over the 2005-2006 period. METHODS: Screening and grading objectives, evaluation criteria and minimum acceptable QA standards were set. To ensure the quality of DR photos, the proportion of nongradable photos in at least one eye had to be less than 10%. To ensure grading accuracy, intergrading agreement had to be greater than 90%. Grader-generated reports had to be available in less than 48 h for more than 80% photos. Readers had to grade 500 to 3000 photos per year. RESULTS: Sixteen screening centres were opened between June 2004 and December 2006, and 14,769 patients were screened. Percentages of nongradable photos were consistently below the QA requirement (less than 10%). Overall, 800 photos were graded a second time by a reader blinded to original grading; agreement between graders ranged from 92 to 99%. More than 90% of grader-generated reports were produced within 48 h. The number of readings by each grader nearly achieved the QA standard. CONCLUSION: QA for DR telescreening should be a continuous process to provide performance feedback, thus guaranteeing a high standard for delivered results. Almost all of the predetermined QA standards in OPHDIAT for screening and grading were met. Besides the quality/sensitivity of the screening/grading modalities, it is important to evaluate at-risk patients so that they can be treated efficiently; this should be addressed in a global QA programme.

Hospital resources used for ectopic pregnancy treatment by laparoscopy and methotrexate.

OBJECTIVE: To compare resources used in the medical and laparoscopic treatment of unruptured ectopic pregnancy. METHODS: We prospectively recorded all the medical resources required in the treatment of unruptured ectopic pregnancy. The study period ranged from January 1, 1995 to June 30, 1998. Single-dose intramuscular methotrexate injections were administered in 55 women (group I). This therapeutic option was provided on an outpatient basis in small EP (beta-HCG level < 5000 IU/L and hematosalpinx diameter < 3 cm). Serial clinical controls and biologic tests were performed until bHCG became negative. Forty women underwent a laparoscopic salpingostomy because they refused the methotrexate regimen or had "social" contra-indications (ie, predictable difficulties in the follow-up) (group II). Twenty-one patients underwent conservative laparoscopic treatment because of "medical" contraindications to methotrexate (group III). We recorded the resources used with the outpatient and inpatient treatment in each group (methotrexate consumption, operating room acts, length of hospital stay, clinical examinations, biological tests, and sonograms during the follow-up). RESULTS: We observed similar cure rates in each group, but it took significantly longer for beta-HCG to become negative in group 1. However, hospitalization was significantly less often required, and the length of hospital stay was shorter in this group. But length of follow-up, number of office visits, biological tests, sonograms, and subsequent readmissions were significantly more frequent after methotrexate. Despite more severe clinical presentations for patients in group III, we didn't find any significant differences in the hospital resources used in this group in comparison with those used in group II. CONCLUSIONS: The outpatient methotrexate option may result in low consumption of resources for a hospital because most of the follow-up can be performed by city practitioners and laboratories. For the laparoscopic option, efforts should be made to reduce the postoperative hospital stay.

[Evolution of polyvalent intravenous immunoglobulins (IVIg) prescription, at the Assistance Publique - Hopitaux de Paris between 1988 and 1997. Results of the plan of action set up in order to regulate the prescription]. / Evolution des prescriptions des immunoglobulines intraveineuses polyvalentes (IgIV) à l'Assistance Publique -Hôpitaux de Paris entre 1988 et 1997.

In 1991 the public hospitals in Paris set up a plan to regulate the prescription of IVIg. The plan includes an expert committee and reliable data collection. The expert committee has a threefold mission: i) perform an annual up-date of IVIg classification using three categories: accepted indications (group I), currently deabated indications (group II), and unwarranted indications (group III); ii) develop guidelines for improved therapeutic strategies; iii) stimulate research. Data on use of IVIg are collected in 16 pilot hospitals. These data designate IVIg prescriptions by indication. Data are centralized by the CEDIT which publishes an annual report. Between 1988 and 1991, prescription of IVIg increased at an average annual rate of 33%. Between 1991 and 1996, the amount of IVIg used leveled off: approximately 330 kilograms/year, excluding research protocols. In 1997 there was a decline to 299 kilograms accounting for a total expenditure of 44 million French francs (US$ 6.7M). In 1997, group I prescriptions represented 80% of all IVIg prescriptions, group II 9.8% and group III 9.1%. Comparison of medical practice with a scientificaly recognised reference made it possible for AP-HP to set up an effective regulation of IVIg prescriptions. The longevity of this evaluation work is by itself a success.

[Photostimulation plates or conventional films for bedside chest x-ray in pediatric radiology? A comparative study of quality of image and the dose delivered to patients]. / Plaques photostimulables ou films conventionnels pour les clichés pulmonaires "au lit" en radiopédiatrie? Une étude comparative de la qualité de l'image et de la dose délivrée aux patients.

Image quality and patient doses received during chest bedside examinations performed with conventional (film-screen combination) and photostimulable phosphorus plate systems were compared in a study carried out in 1993 in a French pediatric radiology department. Seventy one children (36 males and 35 females) aged between 9 days and 18 years (average: 43 months) were included in the study. Technical performances of all radiological equipment used were permanently checked through a quality control program. One conventional and 3 "photostimulable" films were performed for each patient included (mAs product selected for "photostimulable" system was progressively reduced down to 60% of that of conventional technique). TLD Lithium Fluoride chips were used to measure entrance surface dose during the examination. Image quality of 284 films (213 "photostimulable" + 71 conventional) was assessed by three independent radiologists. Advantages and drawbacks of both studied imaging techniques are discussed in terms of patient dose reduction and image quality.

Transrectal and transurethral hyperthermia versus sham treatment in benign prostatic hyperplasia: a double-blind randomized multicentre clinical trial. The French BPH Hyperthermia.

OBJECTIVE: To compare the safety and efficacy of hyperthermia for the treatment of benign prostatic hyperplasia (BPH), by either the transrectal or transurethral approach, relative to sham treatment. PATIENTS AND METHODS: Two hundred patients from seven urological departments were randomized and treated in a single centre. Principal inclusion criteria were a peak flow rate (PFR) < 15 mL/s and residual urine < 300 mL/s. Comparisons were made between transurethral hyperthermia (TUH) and transurethral sham (TUS) and between transrectal hyperthermia (TRH) and transrectal sham (TRS) 12 months after treatment. Outcome was assessed by improvements in the Madsen score and PFR, and the incidence of side-effects. RESULTS: After 12 months, 145 patients were evaluated; 12 patients withdrew during treatment, 43 withdrew during follow-up and two were lost to follow-up. Withdrawals were mainly due to side-effects during treatment (17% in the TRH and 1.5% in the TUH group) and to a lack of improvement during follow-up (14% in the TUH group, 19% in the TUS, 15% in the TRH and 10.5% in the TRS group received other treatments for BPH). Complications during treatment consisted mainly of local pain, urethral bleeding, urethral pain and acute retention, and were five times more frequent in the TRH than the TUH group (34% versus 6%). There was no improvement in PFR after TUH and TRH (response < 20%). Only TUH improved the Madsen score (TUH, +50% and TUS, +17%). CONCLUSION: Hyperthermia was not an effective treatment for BPH.

[Cost effectiveness of methotrexate treatment of ectopic pregnancy]. / Evaluation coût-efficacité du traitement de la grossesse extra-utérine par le méthotrexate.

OBJECTIVES: Compare the cost of managing unruptured extra-uterine pregnancy with methotrexate injections and with conservative laparoscopic surgery. METHODS: Review of the literature to quantify post-therapeutic follow-up after echoguided methotrexate injections or laparoscopic salpingotomy. The cost of each procedure was determined on the basis of the French National Health Insurance nomenclature (Caisse National d'Assurance-Maladie). Total costs thus induced were then compared. RESULTS: The cost of medical treatment for unruptured extra-uterine pregnancy was similar to laparoscopic surgical treatment (10,267 and 11,858 FFr respectively). The duration of hospitalization was short for methotrexate injection but the number of biology examinations required for post-therapeutic follow-up was greater. CONCLUSION: Cost of medical treatment and laparoscopic surgical treatment reported in the literature vary little. Ambulatory methotrexate injections and the major reduction in biology follow-up examinations are required for significant reduction in medical treatment costs. Rigorous patient selection for methotrexate treatment could both improve effectiveness and reduce costs. Eliminating anaesthesia-related mortality as well as any surgery would be the true beneficial effect of medical treatment.

[Managing of an innovation in health care: the case of polyvalent intravenous immunoglobulins at the Assistance-Publique-Hôpitaux de Paris]. / La maîtrise de la diffusion d'une innovation en Santé: le cas des immunoglobulines intraveineuses polyvalentes à l'Assistance Publique-Hôpitaux de Paris.

Managing new innovations in medicine is a particularly timely subject. There is an abundant history concerning over expectations resulting from the development of new treatments or diagnostic procedures, some shown to be less effective than promised, others even found to be dangerous. A new aspect to the question is the importance of economic pressures which require rational investment decisions when diffusing innovating technologies. In 1991, the Commission for the evaluation and diffusion of innovating technologies (CEDIT) at the University Hospitals of Paris (Assistance Publique-Hôpitaux de Paris) developed a programme aimed at better managing the distribution and use of polyvalent intravenous immunoglobulins (IgIV), a new promising therapeutic tool with both a high cost and a certain number of risks. The programme was designed to assist prescribers in elaborating better therapeutic strategies and to help hospital managers rationalize expenditures for IgIV. The results of this experience are presented here together with certain conclusions concerning the way management decisions can be applied to the diffusion of an innovation in health care.

[The economic evaluation of prostatic hyperthermia]. / L'évaluation économique de l'hyperthermie prostatique.

UNLABELLED: The aim of this study is to assess the hospital cost of treating Benign Prostatic Hyperplasia (BPH) by hyperthermia. The cost analysis was conducted simultaneously with a randomized clinical essay comparing hyperthermia to sham; the analysis was promoted by the Committee for Evaluation and Diffusion of Innovative Technologies (CEDIT) of the AP-HP. Cost components are: medical and paramedical staff salaries, supplies, overhead and capital costs. RESULTS: cost per session varies from FF 1200 to FF 5300; cost per treatment varies from FF 2500 to FF 9700 depending upon the equipment used. For comparison, annual drug treatment of BPH varies from FF 2600 to FF 2900. CONCLUSION: important variation in the treatment cost of BPH by hyperthermia is observed depending on the equipment used. Clinical data do not demonstrate improved efficacy with the costlier hyperthermia treatments. Drug treatment seems to be more cost effective than hyperthermia for BPH treatment.

[Cost of intensive treatment followed by autograft of circulating stem cells. Application to multiple myeloma]. / Coût d'un traitement intensif suivi d'une autogreffe de cellules souches circulantes. Application au myélome multiple.

OBJECTIVES: Legitimate efforts to reduce health care costs, especially of intensive protocols including transplantation for haematological diseases, require realistic economic evaluations. We determined the direct cost of intensive chemotherapy associated with total body irradiation and autologous blood stem cell transplantation in patients with multiple myeloma. METHODS: Ten consecutive patients (7 males, 3 females) with Stage II or II multiple myeloma, who had received no prior treatment and were under the age of 55, were included in the study. Peripheral blood stem cells were collected by successive cytaphereses after a short period of aplasia induced by a CHOP protocol. During this period, the patients were in normal hospital rooms. A VAMP protocol was then administered in three 4-day sessions. Intensive therapy was started 1 month later with CCNU, etoposide, cyclophosphamide and melphalan. Total body irradiation (12 Gy) was performed on days -3, -2, -1. Autologous grafting was done on day 0. The intensive therapy was followed by a period of aplasia and the patients were protected in laminar flow rooms. Regular antibiotic and haematologic protocols were applied. Growth hormone was not given. The patients were seen regularly for follow-up and interferon alpha 2b was prescribed for 5. RESULTS: The mean cost of the two year treatment was 468,392 +/- 167,467 French francs. Personnel accounted for 36% of the total cost, marrow collection 13%, blood products 9.8%, laboratory tests 8.2% and drugs 7.2%. Little data are available in the literature of comparable cost analyses in other French hospitals or in other countries. CONCLUSION: Controlled cost/benefit studies should be conducted to enable a rigorous comparison between different therapeutic strategies.

Photorefractive keratectomy in 176 eyes: one year follow-up.

Beginning in March 1992, 176 eyes from 176 patients underwent photorefractive keratectomy with the Summit Technology Eximed UV200LA. This study was designed to evaluate the efficacy of this method.

[Ultrasound attenuation in calcaneus and bone density]. / Atténuation des ultrasons au calcanéum et densités osseuses.

Broadband ultrasound attenuation (BUA) is a new technique for investigating bone status. We evaluated its use in osteoporosis. To assess in vivo reproducibility, we determined the coefficient of variation (cv) on the basis of five measurements (with repositioning) of the same foot in 50 women. The cv was 2.8 +/- 1.7%. BUA values were similar in the right feet and left foot and were correlated with bone density in the calcaneal area investigated (r = 0.8, p < 10(-4). BUA of the calcaneus was correlated with bone density in the lumbar spine, femur, and forearm in 240 healthy postmenopausal women (correlation coefficients 0.36 to 0.55; p < 10(-4)). BUA decreased with age, with a sharper drop during the first years following menopause. Mean broadband ultrasonic attenuation in 37 females with osteoporosis (58.92 +/- 11.59 dB/MHz) is lower than controls (66.10 +/- 15.29 dB/MHz, p = 0.04). Areas under receiver operating characteristic curves, used to evaluate the discriminating value of BUA in osteoporosis and osteopenia, were 0.79 and 0.72, respectively. The kappa coefficient of concordance between BUA and spinal density was 0.59. These data demonstrate that BUA cannot replace bone density measurements. Prospective studies are needed to investigate the potential role of this technique for identifying women at high risk for osteoporotic fractures.

[Value of techniques of measurement of bone. Radiological methods and contribution of ultrasonics]. / Intérêt des techniques de mesure de la masse osseuse. Méthodes radiologiques et apport des ultrasons.

The current interest in bone mineral density measurements is related to the frequency, the morbidity and the cost of osteoporosis, which is considered to be a public health problem in developed countries. The main risk factor of osteoporotic fractures is the reduction of bone mineral density. This risk factor can be prevented by hormonal therapy in post-menopausal women. So it is of interest to develop the bone mineral density measurement methods, in osteoporotic bone areas or the entire skeleton (absorptiometry). But the interpretation of the result in term of individual fracture risk, the choice of the bone site to be examined, and the indication of the measurement are still being discussed. A new method of bone status evaluation is currently available: the broad band ultrasonic attenuation, which measures the attenuation of ultrasounds through the calcaneus bone. The device is portable, inexpensive and radiation free, and may give quantitative and qualitative assessment of bone. However, the normal values, the relation with the absorptiometry results and the contribution of this method in fracture risk evaluation are currently studied. Osteoporosis risk evaluation is an important point of health management in post-menopausal women and elderly people. Large prospective studies with the different methods are in progress.

[The cost of HIV infection: method and results]. / Le coût de l'infection à VIH: méthode et résultats.

The project concerned hospital costs: in-patient, out-patient, clinics and home-hospitalisation. It included asymptomatic HIV-infected individuals as well as AIDS patients. The annual cost per patient was calculated according to the various types of disease management described by involved physicians. Standard annual per-patient cost was between 2,470 and 338,000 according to the severity of the disease (four stages of severity have been defined). The standard annual cost per HIV-infected patient with Kaposi's sarcoma was in the range FF 89,000 to FF 131,000. The standard cost of surveillance for an asymptomatic HIV-infected pregnant woman was just over FF 3,400. The standard annual cost per child born to an asymptomatic HIV-infected mother was FF 12,300 for a child enrolled in an epidemiology protocol; it was FF 42,000 or FF 196,000 for a child with AIDS according to the severity of the illness. Furthermore, the study highlights the heterogeneity of medical practice, greater in the earlier stages of the disease, and the incidence of difference forms of disease management upon costs.

[Collection and elaboration of the economic information necessary for calculating the costs of therapeutic decisions]. / Collecte et élaboration de l'information économique nécessaire au calcul des coûts de la décision thérapeutique.

This article presents a method of evaluating the cost of hospital medical practice. The method used the concept of standard cost to determine these activities. After reviewing the different concepts of cost used by economists, the value of using standard cost for this type of evaluation is demonstrated. This approach has the advantage of making physicians aware of the cost of the decisions they make during their everyday medical activities. The standard cost approach is completed by an evaluation of medical activities in direct cost, so preserving a medical significance of the cost analysis. The method involves breaking down protocols or medical activities into physical modules, the costs of which are calculated. There are three main categories of physical module in the hospital: duration of hospital stay, medico-technical investigations (biology, functional investigations, imaging...) and specific acts (coronary angiography, open heart surgery, angioplasty, pulmonary scan, organ transplants, etc...). When the cost of these modules has been calculated, the frequency of each in the given medical speciality has to be measured and, thereby, the total cost of the technology or medical practice can be assessed. However, this method is based on the hypothesis that the average direct cost calculated is representative of the real consumption of resources in the given practice, which is not always the case. Further decomposition of the physical modules may therefore be required in order to attain this significance while taking care to preserve the medical reality of each module.

[Development of the indications for extra-corporeal lithotripsy and the impact of organizational methods on the indications]. / Evolution des indications de la lithotripsie extra-corporelle et impact du mode d'organisation sur les indications.

A technology assessment of ESWL for renal stones has been conducted. The development of lithotripsy during the early phase of diffusion of the technique was studied retrospectively for 1985 and 1986. This study permitted the comparison of lithotripsy practice in Paris with that in Lyon. Results show that the proportion of small (less than 10 mm) stones increased from 39% at the beginning of the period to 60% at the end in Paris and simultaneously from 41% to 53% in Lyon. The location of the calculi treated by ESWL changed significantly over the period, but only in Paris where the number of caliceal stones went from 62% to 38% and that of ureteral stones from 1% to 8%. Neither the number of stones treated during one ESWL session, nor the length of hospital stay, changed significantly during the first years of use of this treatment. However, if one excludes hospital stays of more than 15 days, the average hospital stay in Paris decreased where as the opposite was observed in Lyon. The impact of the organization of ESWL users upon medical practice is obvious in relation to the size of stones: in Lyon, where one team provides ESWL therapy for all hospital urology departments, treatment practice is more homogeneous than in Paris and more closely a resembles the international consensus.

Cost of allogeneic bone marrow transplantation in four diseases.

The cost of bone-marrow transplantation is compared in 4 diseases: acute myelogenous leukaemia, severe combined immunodeficiency, severe aplastic anaemia and chronic granulocytic leukaemia. Hospital cost components directly related to the clinical protocols applied are valorized. Results confirm the well-known fact that bone-marrow transplantation is a costly technique. The unit cost of a transplantation can vary from 1 to 2 between departments for the sole reason that patients treated are not suffering from the same illness. For one disease, the unit cost may vary from 1 to 2.7 when post-graft complications arise. Furthermore, in the health-care sector, as well as in every other economic sector, costs do not remain stable: they vary in time most especially when treatment protocols evolve. This type of cost information is the basis for management control systems without which physicians, hospital managers and health-care authorities cannot communicate effectively. In countries where health care is largely financed by the community, what is at stake is the future of advanced technologies in medicine.