Linguistic validation of the DN4 for use in international studies.

OBJECTIVES: Traditionally, pain is divided into two main groups: nociceptive pain due to an excess of nociception and neuropathic pain associated with an injury or dysfunction of the central or peripheral nervous system. The French neuropathic pain group has developed a specific questionnaire, the DN4, to help clinicians in the differential diagnosis of neuropathic and non-neuropathic pain. In order to allow this questionnaire to be used in international studies, it has been translated and linguistically validated into Dutch, German, Greek and Hungarian, using a well-established procedure. METHODS: The same method was used for each country and involved four stages: (1) two forward translations followed by comparison and reconciliation of the translations, (2) one backward translation, (3) review by an expert clinician, and (4) cognitive testing of the first seven items on patients. RESULTS: The translation work produced three types of situations. Either the original wording could be translated literally or semantic issues were discussed as the original wording was not always sufficiently clear and had to be clarified by adding an explanation, or, in the case of idiomatic phrases such as "pins and needles", it was necessary to use different expressions, the challenge being to retain the original concept while doing so. The versions proposed to patients and experts were well understood. CONCLUSION: The DN4 items were linguistically validated in each of the target languages, thus providing the means for standardising the diagnosis of neuropathic pain and pooling the data collected during clinical research in the different countries involved.

Management of ileocutaneous fistulae using TNP after surgery for abdominal malignancy.

Enteric fluids produced by enterocutaneous fistulae can cause severe inflammation in the surrounding skin. By removing these corrosive fluids, topical negative pressure can help maintain skin integrity and promote spontaneous closure.

[Quality of life and angina pectoris. Comparison of the effects of 2 nitrate derivatives administered discontinuously: transdermal 10 mg nitroglycerine patch (12 hours) and long-acting oral 40 mg isosorbide-5-mononitrate (once a day)]. / Qualité de vie et angine de poitrine. Comparaison des effets de deux dérivés nitrés administrés de façon discontinue: trinitrine 10 mg, 12 heures, par voie transdermique, et isosorbide-5-mononitrate à libération prolongée 40 mg, monoprise, par voie orale.

A comparative, randomised, 12-week (two periods of six weeks) cross-over study including 150 patients (mean age: 63.4 years) suffering from stable but symptomatic (a minimum of three attacks per week) angina pectoris was performed in order to compare the effect on quality of life of two discontinuous nitrate treatments: transdermal 10 mg nitroglycerine patch (12 hours) and long-acting oral 40 mg isosorbide-5-mononitrate (once a day). The efficacy and safety were also compared. The two treatments equally and significantly improved patients' quality of life. The number of attacks and sublingual nitrate consumption significantly decreased under treatment. Attack severity was lower under nitroglycerine than isosorbide-5-mononitrate treatment. Finally, even though nitroglycerine more frequently induced headache than did isosorbide-5-mononitrate (13 cases versus 8), patients, and in particular those having received nitroglycerine treatment in the second period of the study, preferred the transdermal nitroglycerine treatment. In conclusion, results did not show any relevant difference in terms of efficacy or tolerability between the two treatments. Nevertheless, the facility of use and the feeling of protection were better under transdermal nitroglycerine patch than oral isosorbide-5-mononitrate treatment.

[Acceptability of local treatment of allergic rhinitis with a combination of a corticoid (beclomethasone) and an antihistaminic (azelastine)]. / Acceptabilité d'un traitement local de la rhinite allergique associant un cortidoïde (béclométasone) et un antihistaminique (azélastine).

A prospective multicentre study involving 219 patients with seasonal or aperiodic rhinitis was performed to assess the acceptability of a local treatment combining antihistamine (azelastine) and corticoid (beclomethasone) drugs. The drugs were administered either together (morning and evening, with a 5-minute interval) or separately (azelastine in the morning and evening, and beclomethasone later during the morning and in the afternoon) for 15 days. Treatment acceptability was measured by a nine-fold questionnaire (7-point scale, mean score per question). Patient participation, protocol and therapy compliance, and treatment efficacy and tolerance were also studied. The acceptability of the association was satisfactory (mean score for general facility of treatment: 4.7/6) and did not differ between administration schedules. Patients found treatment easy, and were not bothered by the bulk of the bottles or the risk of mixing them up. This acceptability was confirmed by the low percentage (4%) of patients refusing to be included in the study (refusing any treatment by nasal spray). The general acceptability was confirmed by the results for therapy compliance, general efficacy and tolerance: 94.9% of the patients took more than 75% of the administrations prescribed, 77.6% of the patients and 85.2% of the practitioners judged treatment efficacy as good or excellent, and 84.6% of the patients and 91.4% of the practitioners judged tolerance as good or excellent. Moreover, most of the adverse events consisted of minor signs of local intolerance, and were identical to those observed when the two treatments were administered alone.

A randomized double-blind placebo controlled study of azelastine nasal spray in children with perennial rhinitis.

One hundred and twenty five children (median age 8.71 years) suffering from perennial allergic rhinitis were treated in a randomized, double-blind, parallel group study comparing azelastine nasal spray 0.14 mg/nostril twice daily (0.56 mg/day) and placebo nasal spray. Medication was given for a period of 6 weeks which followed a 2 week placebo washout period in all patients. Subjects were aged between 5 and 12 and were skin prick positive to either house dust mites and/or cat or dog dander. Concomitant anti allergic treatment was not permitted during the study. Severity of rhinitis symptoms was scored daily by the child or his/her parents on a diary card using a visual analogue scale (VAS) for each evaluated symptom: 0, absent-100, could not be worse. Mean weekly scores were calculated. Symptoms evaluated were: sneezing, nasal blockage, nasal itch and rhinorrhea. In addition, at each clinic visit the investigator evaluated symptoms using a verbal score of 0, no symptom-3, severe. Compared to the baseline, for each of the six study weeks, the reduction in the VAS scores for all four symptoms was statistically greater for the azelastine group compared to the placebo group. The investigator's assessment at clinic visits bore out these results. Both azelastine nasal spray and placebo were well tolerated, no serious adverse events were reported. During the treatment phase of the study a total of 36 adverse events were reported by 25 patients (azelastine 10, placebo 15). The most frequently occurring events were pharyngitis (azelastine 5, placebo 3), cough (azelastine 3, placebo 1) and bronchitis (azelastine 1, placebo 3). In conclusion, azelastine has been shown to be effective in the treatment of perennial rhinitis in children aged 5-12 years and to be superior to placebo in the relief of all symptoms assessed, namely sneezing, nasal blockage, nasal itch and rhinorrhea.

Breast cancer: zones of increased density mammographic features, correlated to clinical TNM and prognosis.

From January 1981 to December 1995, 8,421 patients having a mammographic opacity corresponding to breast cancer were examined. The opacities were divided into two groups: zones of increased density (ZID), (1,449 patients), and a reference group comprising all other types of opacities (6,972 patients). Mammograms were reviewed retrospectively, as well as clinical, histological and biological parameters in both groups. Diagnosis of ZID was often difficult, sometime's guided by the presence of microcalcifications, which were more frequent. Sonography and direct mammographic magnification proved to be particularly helpful for a correct diagnosis. Most prognostic factors were poorer in ZID as compared to the reference group. The 5 year survival rate was 78% (84% for the reference group). Breast cancer that appears on mammograms as a ZID is often more difficult to diagnose and factors of poor prognosis are more often observed than in breast cancer with other types of opacities. To improve their detection sonography and direct mammographic magnification can be very helpful.

Clustered breast microcalcifications: evaluation by dynamic contrast-enhanced subtraction MRI.

OBJECTIVE: Our goal was to evaluate dynamic contrast-enhanced subtraction MRI in the diagnosis of isolated clustered calcifications of the breast. MATERIALS AND METHODS: One hundred seventy-two patients underwent surgical biopsy for isolated clustered breast calcifications. Their mammograms showed round (n = 88) or linear/irregular (n = 84) microcalcifications. All patients had a preoperative Gd-DOTA-enhanced subtraction dynamic study. Any early contrast enhancement in the breast parenchyma concomitant with early enhancement of normal vessels was considered positive. RESULTS: Fifty-eight in situ carcinomas, 22 invasive carcinomas, and 92 benign lesions were found at histological analysis. Dynamic MR sequences showed early contrast enhancement in 76 of 80 malignant lesions (sensitivity 95%) and in 45 of 92 benign lesions (specificity 51%). Two invasive and two intraductal carcinomas did not show early contrast enhancement. Three independent observers agreed in rating early contrast enhancement in 143 of 172 lesions. CONCLUSION: Poor specificity limits the diagnostic accuracy of dynamic contrast-enhanced subtraction MRI in distinguishing benign from malignant microcalcifications on mammography.

[Prevalence of ragweed hayfever in the south and east of the greater Lyon region in 1993]. / Prévalence de la pollinose à l'Ambroisie dans le Sud et l'Est de l'agglomération de Lyon en 1993.

In December 1993, AFEDA conducted an epidemiological survey in order to establish the prevalence of ragweed-induced pollinosis and to evaluate how well the public was informed about this danger. A survey by telephone was made, taking a random sample of the population drawn by lot from telephone directories in the Rhône district. This involved about 300,000 homes. Those in which at least one person was under 50 were questioned. The questionnaire included a section aimed at everyone, and another section aimed at homes where at least one person suffered from pollinosis in August and/or September, in Lyon. 1,800 homes were selected at random, 905 persons responded: 22.4% were off target, 77.6% matched up to the chosen target. Of these, 32.9% were aware of Ragweed and 31.9% knew of the dangers. The 702 homes targeted made a total of 2,060 persons, 59.6% of which live in town and 40.4% in suburban areas; 51.6% are women and 48.4% men. 53 people, i.e. 2.57%, presented at least one of the following symptoms in 1993: rhinitis 86.8%, conjunctivitis 69.8%, itching of the pharynx and/or ears 47.2%, tracheitis and/or asthma 41.5%. 77.4% received medication. In 1993, the prevalence of ragweed-induced symptoms is a certainty for 1.8% of the population, if we evaluate only those patients presenting these symptoms every year. This prevalence therefore does not take account of new cases nor of newcomers to the district. Moreover, we have probably under-estimated this prevalence, owing to the torrential rain that fell in Lyon in late August 1993. This made a break in the pollen curve, a phenomenon that has never yet been observed in 13 years of recording pollen calendars.

[Diagnosis of non-palpable breast lesions: contribution of cytological punctures after stereotaxic localization]. / Diagnostic des lésions mammaires non palpables: apport des ponctions cytologiques après repérage stéréotaxique.

The authors reviewed the accuracy of stereotaxic fine-needle aspiration cytology. Two hundred-twenty-eight lesions were studied: 103 benign lesions, 125 cancers. Inadequate sample was obtained in 26% of cases. None of the cytology reports were false-positive, whereas 77% of the suspect cytologic reports were malignant on histology. In strongly suspicious lesions at mammography, the decision to perform surgical biopsy should not be postponed as false negative cytologic findings (7 cases) are possible. In patients with a low suspicious lesion, cytology found six cancers. The benign-to-malignant ratio of excisional biopsies of non palpables lesions should be reduced by stereotaxic fine-needle aspiration cytology.

Correlates of somatic causal attributions in primary care patients with fatigue.

Researchers in the field of chronic fatigue in tertiary care found that patients' somatic (e.g. viral) explanations for their condition may lead to chronicity of symptoms. We studied the influence of a somatic attributional bias on outcome and reported symptoms in primary care patients with fatigue. We compared fatigue scores on a specific scale, and number of presented symptoms, in two groups of primary care patients with 'functional' fatigue: 75 with a high score on the somatic subscale of the Fatigue Attribution Scale (S-FAS), and 95 with a low score on the S-FAS. At the index visit, patients with low and high scores on the S-FAS were not different for age, sex, fatigue scores, and levels of depressive symptoms. Patients with high scores on the S-FAS presented significantly more somatic and psychological symptoms-a total of 36 symptoms for 24 patients (25.3%) in the low-score group, and a total of 52 symptoms for 31 patients (41.3%) in the high-score group. Forty-two days later, at the follow-up visit, the fatigue scores were similar in both groups. In primary care patients with fatigue not due to somatic illness or major depression, the tendency to attribute fatigue to somatic causes is not associated with a worse outcome, but with a higher number of reported symptoms.

Quality of life and insomnia validation study for a specifically designed questionnaire.

A questionnaire was devised to assess changes in the quality of life of insomniac patients when treated by a hypnotic. The questionnaire was validated in two groups of patients (60 non-insomniac and 52 insomniac patients). The results of this study confirmed the relevance of the questionnaire and its power to distinguish between the two groups of patients. A second study carried out simultaneously in 58 insomniac patients receiving treatment showed the internal reliability of the questionnaire and its reproducibility after 3 to 5 days.

Quality of life after the menopause: influence of hormonal replacement therapy.

OBJECTIVE: Our purpose was to demonstrate the clinical efficacy and effect of hormone replacement therapy in menopause on quality of life. STUDY DESIGN: A randomized, open, 6-month comparison of hormone replacement therapy (estradiol transdermal system [Estraderm TTS] plus chlormadinone) and symptomatic treatment (verapipride) was performed. Analysis was by intention to treat. RESULTS: In 499 postmenopausal women with moderate and severe symptoms enrolled by 101 physicians, hormone replacement therapy was superior to symptomatic treatment on all assessments of quality of life and clinical efficacy. The effects were independent of the incidence of hot flushes. CONCLUSION: The effect of hormone replacement therapy on the quality of life of postmenopausal women was significantly superior to symptomatic treatment.

Mammographic features of 455 invasive lobular carcinomas.

Of 6,009 cases of breast cancer studied, 455 (7.6%) were invasive lobular carcinoma (ILC); 341 of these (75%) were pure ILC and 114 (25%) were ILC mixed with ductal forms. The mammographic features were compared with those of the 5,554 other breast carcinomas. Pure ILCs were less frequently round (1% vs 11%) and more frequently spicular (28% vs 23%) or with architectural distortion (18% vs 6%) than the other breast carcinomas. Microcalcifications were less common (24% vs 41%) and retraction of the skin (25% vs 21%) and nipple (26% vs 17%) was more common in pure ILC than in the other breast carcinomas. When complementary magnification views were obtained, only 50% were helpful in diagnosis of ILC while 75% were helpful in diagnosis of other breast carcinomas. Malignancy was less frequently diagnosed in ILC (57%) than in the other breast carcinomas (64%). The results were intermediate in the mixed ILC group.

[EMLA analgesic cream for venopuncture during anesthetic induction in children]. / Crème analgésique EMLA pour la ponction veineuse lors de l'induction anesthésique chez l'enfant.

A prospective study was designed to assess the quality of skin analgesia provided by the EMLA anaesthetic cream, an eutectic mixture of local anaesthetics (prilocaine and lidocaine). The children, aged 3 months to 15 years, and scheduled for genital and urinary surgery, were allocated to two groups, those aged less than or equal to 5 years (35 +/- 14 months, n = 17), and those aged greater than 5 years (97 +/- 26 months, n = 22). The cream (1.6 +/- 0.6 g) was applied by a nurse in the ward as a thick layer on the area of skin to be anaesthetised (on the dorsum of the hand and at the elbow), and covered by a closed adhesive dressing. This required 2.6 +/- 1.7 min, and was considered to be very easy (72%) or easy (28%). The venepuncture (22 or 20 gauge catheter) was carried out by one of the seven anaesthetists of the paediatric surgical units, 92 +/- 51 min after the cream had been applied. The children aged less than or equal to 5 years complained of pain of intensity 7.5 +/- 2.2 (CHEOPS scale, range 4 to 13) and, for those aged greater than 5 years, 24 +/- 21 on a visual analogic scale (range 0 to 100). Local adverse effects occurred in ten patients (skin paleness, erythema, or both). It was concluded that EMLA cream provides convenient analgesia for venepuncture in toddlers and children.

[Clinical study of EMLA analgesic cream in pediatric locoregional anesthesia]. / Etude clinique de la crème anesthésique EMLA en anesthésie locorégionale pédiatrique.

The advantage of EMLA cream for regional blocks (spinal or caudal blocks) was assessed in 46 children. The study included three groups: group 1, with 1 to 6 month-old children (n = 11); group 2, with children aged between 6 months and 5 years (n = 21), scheduled for emergency surgery and with full stomach; group 3, with 5 to 10 year-old children (n = 14), who were to have a regional block as an alternative to general anaesthesia. The cream was applied as a thick layer on the area of skin to be anaesthetised and covered by a closed adhesive dressing, approximately 2.2 h before performing the regional block. A dose of 1 to 2 g was used in children of more than 1 year, and 0.5 to 1 g for those of less than 1 year. All the blocks were carried out by the same anaesthetist. The technique was considered as being little (45/46) or not constraining (1/46). Patient cooperation in carrying out the regional block was judged to be good or very good in 34/46 children. Additional sedation was required in 7 children of groups 2 and 3. The block was as easy to carry out as usual in 37/46 children. In all three groups, most children complained of little or no pain. Local adverse effects occurred in 19/46 patients, consisting of erythema (14), skin paleness (4), or both (1). The investigator qualified the use of EMLA cream as satisfactory or very satisfactory in 36/46. It is concluded that EMLA cream provides convenient analgesia for regional blocks in toddlers and children.

[The value of preoperative location of microcalcifications without palpable breast tumors]. / Intérêt du repérage pré-opératoire des microcalcifications sans tumeur mammaire palpable.

In 1986 and 1987, 224 patients were operated on for microcalcification without palpable lesions of the breast. Classical orthogonal (perpendicular grid) localisation was performed in 123 patients: external cutaneous localisation of the nipple was performed in 78 patients and hook localisation in 25 patients. Primary excision without the need for re-excision was possible respectively in 88% and 94% with external and hook localisation and in 83% after orthogonal localisation. The mean volume of the operation specimen was lower after hook (38.3 cm3) than after cutaneous or orthogonal localisation (54.6 cm3). 43% of the patients had a malignant lesion and even when the cluster of microcalcifications was single 50% of the margins were positive. Pre-operative localisation of occult breast lesions has simplified the surgical technique of excision. Nevertheless the pre-operative diagnosis of malignancy should be improved on in order to perform a procedure both diagnostic and therapeutic in the same operation.

[Affective disorders in the AMDP-4 psychopathological scale]. / Les troubles affectifs dans l'échelle psychopathologique AMDP-4.

The AMDP-4 Psychopathology rating scale contains a category on "Disturbances of affect". It seemed interesting to us to define and explicit the items of this category since "affectivity" is an ill-used concept because it is ill-defined. The same holds for different terms connected to this concept: feelings, emotions, sensations, affects, sensitivity etc. It should be emphasized that the present contribution could only be done thanks to the psychopathological richness of the AMDP; with the most widely used rating scales, it would have been meaningless.

[Diagnostic value of clustered microcalcifications discovered by mammography (apropos of 227 cases with histological verification and without a palpable breast tumor)]. / Valeur diagnostique des microcalcifications groupées découvertes par mammographies. (a propos de 227 cas avec vérification histologique et sans tumeur du sein palpable).

UNLABELLED: Excisions with histological examination were performed in 227 cases of breast microcalcifications without palpable tumor. 99 benign lesions, 27 borderline lesions and 101 carcinomas, 58 of them in situ, were found. Different radiological parameters were studied in relation to histological results: According to the morphology of the calcifications, a classification of 5 types was made. Type 1: annular: 100 per cent were benign lesions. Type 2: regularly punctiform: 22 per cent were malignant lesions. Type 3: too fine for precizing the shape: 40 per cent were malignant lesions. Type 4: irregularly punctiform: 66 per cent were malignant lesions. Type 5: vermicular: 100 per cent of the lesions were malignant. The number of calcifications was higher in carcinomas and 56 per cent of the lesions with more than 30 calcifications were malignant. Close grouping: when there were more than 10 calcifications within a 5 mm diameter area, 57 per cent of malignant lesions were found. Several clusters: 70 per cent were correlated with malignant lesions. Uneven sizes: no signification. LOCATION: the rare retroareolar location correlated with benign lesions in 64 per cent of the cases. Furthermore, the malignant lesions were rare (24%) in women under 40 years of age. For these young women, the authors suggest to directly excise the most suspicious microcalcifications as based on the factors of suspicion and to simply follow the other cases.

[Management following mammography revealing grouped microcalcifications without palpable tumor]. / Conduite à tenir devant une mammographie révélatrice de microcalcifications groupées, sans tumeur palpable

On the basis of a series of 60 cases, the authors report their experience of excision of grouped microcalcifications detected at mammography in the absence of any clinical sign. The breast zone in which the microcalcifications were located by the radiologist was removed surgically. Per-operatoire X-ray of the excised specimens using a mammography apparatus confirmed that the microcalcifications had been totally removed. In addition it was useful to locate aceuretaly the calcifications in view of a careful histological examination of the area. The technique led to the discovery of 27 carcinomas at a sub-clinical stage. A classification of the various types of microcalcification was established in relation to histology. It will be of assistance in suspecting malignancy on the basis of mammography findings in the majority of cases. Excision can then be reserved for cases of presumed malignancy or where a doubt exists. By detecting breast carcinomas at a sub-clinical stage, the method makes possible early and minimally mutilating treatment with the best chances of cure.