Identification of discrepancies between adverse drug reactions coded by medical records technicians and those reported by the pharmacovigilance team in pediatrics: An intervention to improve identification, reporting, and coding.

OBJECTIVE: To identify the discrepancies between the adverse drug reactions (ADRs) identified by medical records technicians and the ADRs identified by the pharmacovigilance team, and to validate the quality of the information collected by the medical records technicians. To propose improvements to the method for detection of serious ADRs by medical records technicians and the pharmacovigilance team to meet the new requirements of Canada's amended Food and Drug Act (Vanessa's Law) and its regulations. METHODS: This was a descriptive and retrospective study. We included all ADRs identified by medical records technicians in the coding of records after hospitalization, including active ADRs present at admission or identified during hospitalization between 1 April 2017 and 31 October 2017, and all ADRs identified and reported by the pharmacy through its pharmacovigilance program during the same period. We identified the discrepancies between the two identification systems and revised all cases from patient records. In addition, we identified improvements in the method for detecting and reporting serious ADRs. RESULTS: This study identified 343 ADRs, 322 of which were coded by the medical records technicians and 21 identified by the pharmacovigilance team for a period of 7 months in a mother-child university hospital center. Only 1.5% of the ADRs were identified by both medical records technicians and the pharmacovigilance team. The code Y43, which corresponds to the largest number of identified ADRs, mainly includes anticancer drugs and immunosuppressant drugs. Three corrective actions were set up: 1) implementation of a form to explain the addition and coding of an ADR to a patient's file, 2) weekly transmission of a working file between the medical records technicians and the pharmacovigilance team so that the files would be reviewed and a declaration made to the regulatory authority, and 3) creation of a standardized pharmacist's note to add to the patient file. CONCLUSION: It is possible to increase the reporting of ADRs, improve the quality of coding, and reduce discrepancies between the ADRs coded by these two teams through a structured intervention.

[Iliac venous leiomyosarcoma revealed by cruralgia: a case report]. / Cruralgie secondaire à une compression par un léiomyosarcome de la veine iliaque: à propos d'un cas.

The iliac venous leimyosarcoma is rare, usually malignant, and often occurs with oedema or phlebitis. We report one case of iliac venous leiomyosarcoma revealed by cruralgia. A 69 years old patient, presented with a left cruralgia which had been developing for three months and which happened after an insignificant trauma. The clinical examination objectified a stiff painful mass of the left iliac fossa together with left psoitis. The initial pelvic tomodensitometry showed a mass at the contact of the psoas muscle. At first, the diagnosis of a psoas haematoma complicated by a compressive cruralgia was evocated. Two months ago, the patient had a pulmonary embolism. At his hospitalisation, considering the persistent cruralgia, a tomodensitometry and a pelvic magnetic resonance imaging were carried out and had shown an heterogeneous mass that was including the iliac vessels. The result of the anatomopathologic examination was leiomysarcoma. Due to the disease's evolution (pulmonary metastasis), only a medical treatment by chemotherapy was undertaken and the patient died a few weeks later. The association of phlebitis and cruralgia should let us think of the diagnosis of vascular neoplasm. Indeed, only an early diagnosis enables a curative treatment.

The effect of 10% povidone--iodine solution on contaminated bone allografts.

The aim of this study was to determine the efficacy of 10% povidone--iodine solution for the decontamination of bone allografts. Bone samples were prepared and tested for sterility using a femoral head removed at the time of primary hip replacement. They were contaminated by a suspension of Staphylococcus epidermidis and ground to measure the quantity of micro-organism attached to the bone. Two levels of contamination were used (1 x 10(3) vs. 1 x 10(4)CFU/mL) to check the efficiency of our method of measurement. Samples of the two groups were decontaminated with 10% povidone--iodine solution using different exposure times. Before decontamination, the count of bacteria attached to the bone was proportional to the bacterial concentration of the contaminating solution. The microbiocidal activity of 10% povidone--iodine solution was the same in both groups. The decontamination time was proportional to the bacterial concentration of the contaminating solution. The results of this preliminary study suggest that a 10% povidone--iodine solution can decontaminate inoculated bone grafts, but a sufficient time of exposure according to the level of contamination must be allowed.

[Difficulty in treating spinal chordoma of the thoracic vertebrae]. / Difficulté de prise en charge des chordomes vertébraux thoraciques.

We report a case of iterative surgery of a spinal chordoma of the 10(th) thoracic vertebra. This kind of neoplasm constitutes 3 to 7% of primary malignant bone tumors. Approximately 50% originate in the sacrum, 35% at the base of the skull and 15% in the true vertebrae. The slow growth delays diagnosis and compromises effective surgical therapy. On the basis of a review of the literature, we advocate an aggressive surgical resection from the beginning, similar to management of solitary vertebral metastasis.

[Mid-term behavior of the bone fixation in non-cemented Miller-Galante 1 total knee arthroplasty]. / Comportement à moyen terme de la fixation osseuse de prothèses totales de genou de Miller-Galante 1 implantées sans ciment.

PURPOSE OF THE STUDY: This retrospective work was conducted to analyze the quality of the bone-implant interface at mid-term in 45 cases treated with a non-cemented Miller-Galante 1 total knee arthroplasty. MATERIAL AND METHODS: All the protheses reviewed were implanted without cement. A patellar implant was cemented in 31.1 p. 100 of the cases. Female sex predominated in this series (77.5 p. 100) and the mean age at operation was 67 +/- 6 years. Pre- and postoperative assessment was based on the HSS score. Mean follow-up was 8.3 years (range 7-11 years). We used the method advocated by the International Knee Society to analyze lucent lines on tibial and femoral implants. Non-parametric tests were used for the statistical analysis with a significance level set at 5 p. 100. RESULTS: The mean HSS score rose from 55 +/- 12 preoperatively to 80 +/- 13 postoperatively, with 62.2 p. 100 good or excellent results at last follow-up. One re-operation was required for aseptic loosening. The femoral implant presented a lucent line in 24.4 p. 100 of the cases at the first follow-up examination only. The tibial implant presented an anterior lucent line at the second follow-up examination then a medial line at the last follow-up in 22.2 p. 100 and 26.6 p. 100 of the cases respectively. Presence of a lucent line (tibial or femoral) on at least one view was significantly correlated with activity (p=0.01) and tibial slope (p=0.0087). DISCUSSION: The disappearance of the lucent lines seen on the femoral component at the second follow-up examination was the expression of its secondary integration. Inversely, we observed an evolution in the lines observed on the tibia. This was probably the result of posterolateral impaction and anteromedial ascension micromovements of the tibial component. An excessive tibial slope was statistically related to development of lucent lines. It increased tibial translation on weight bearing and probably induced an abnormal alteration of the polyethylene. We did not observe any case of massive osteolysis of the tibial metaphysis as described in the literature for non-cemented knee arthroplasties. The screws of the Miller-Galante 1 prosthesis do not protrude from the tibial implant (which would risk generating polyethylene debris) and the pieces used (screws and implants) are all made of the same metal. CONCLUSION: The quality of primary fixation of the non-cemented Miller-Galante 1 tibial implant was not totally satisfactory at mid-term. Inversely, simple impaction of the femoral component was sufficient to ensure stable positioning.

Subacromial impingement: influence of coracoacromial arch geometry on shoulder function.

OBJECTIVE: To find correlations between radiological coracoacromial arch geometry and shoulder function in patients with subacromial impingement syndrome. PATIENTS AND METHODS: During a prospective study of the efficacy of arthroscopic subacromial decompression, we evaluated the function of the treated and contralateral shoulders using Constant's functional score and confronted the results to several radiographic parameters reflecting coracoacromial arch geometry. RESULTS: Constant's score values were low (42 +/- 15) because of pain and a low level of activity. Males had significantly higher scores than females. Constant's score was unaffected (P > 0.05) by patient age, the side, the level of activity, or the duration of symptoms, but was significantly influenced by the orientation of the acromion with respect to the scapular spine and to the vertical scapular axis. The preoperative Constant's score was significantly higher in patients with a more horizontal acromion (P = 0.01). A very tight correlation was found between the preoperative Constant's score and the angle between the acromion and scapular spine (P = 0.0003). CONCLUSION: Based on our results, we defined an open and a closed coracoacromial arch geometry. Coracoacromial arch geometry is correlated with shoulder function syndrome and can assist in the interpretation of rotator cuff impingement.

[Brain abscess following the use of skull traction with Gardner-Wells tongs]. / Abcès cérébral secondaire à l'utilisation de traction crânienne par étrier de Gardner-Wells.

Brain abscess after insertion of skull traction is a rare and serious complication. Its development is secondary to superficial infection. Adequate preventive measures have to be taken: proper sterile dressing and daily care. Signs of local irritation are not always synonymous with skull migration. When gradual loosening of the skull occurs, especially associated with superficial infection, the pins must not be tightened. The more appropriate management is to investigate for penetration of the inner cranial cave. When in doubt, repositioning the pins may be necessary, as well as establishing an aggressive treatment against cutaneous infection.

[Iatrogenic intra-arterial injection during sclerotherapy of the external saphenous vein]. / Injection intra-artérielle iatrogène au cours d'une sclérose de veine saphène externe.

Inadvertant intra-arterial injection is a rare complication of sclerotherapy of varicose veins. We report one case of accidental popliteal injection complicated by acute ischemiae of the posterior compartment of the leg who needed fasciotomy and Achillus tendum elongation. There is no practical "step-by-step" guide of these complications and the best treatment is the prevention by respect of contraindications and the injection of sclerosing agent under ultrasonographic control.

[Long-term outcome of Charnley's femoral implant. A review of 309 cases with follow-up of minimum 20 years]. / Comportement à long-terme de l'implant fémoral de Charnley. Revue de 309 dossiers avec un recul minimum de 20 ans.

PURPOSE OF THE STUDY: We evaluated the results of 309 femoral components of total hip arthroplasties performed using Charnley prosthesis and cement, by one surgeon, between January 1972 and December 1975. MATERIAL AND METHODS: Observations and measurements were based on standard pelvic X-rays. Survivorship curves were calculated to evaluate femoral component failures at twenty years of follow-up. We compared the effect of different parameters on the femoral implant loosening. RESULT: At 20 years of follow-up, 82 hips were included in the study, 227 were expelled: 109 by death, 52 by revision and 66 by loss for follow-up. Probability for death, at 20 years follow-up, was 40.7 per cent, probability for revision was 33.9 per cent, for femoral loosening was 16 per cent. The rate of aseptic femoral loosening was higher for men, with high activity and varus position of the femoral stem. Statistical analysis showed correlation between calcar resorption and femoral loosening, between polyethylene wear and calcar resorption. No directly significant correlation was established between polyethylene wear and femoral loosening. DISCUSSION AND CONCLUSION: This study confirms relations between polyethylene wear, calcar resorption and femoral loosening and underlines the influence of mechanical factors on femoral loosening. Femoral stem positioning is very important for femoral loosening. Varus position is clearly unfavourable. According to ours results, the best position is with a slight valgus.

[Experimental protocol for mechanical characterization of a femoral implant of carbon-Peek composite hip prosthesis in fatigue]. / Protocole expérimental pour la caractérisation mécanique en fatigue d'un implant fémoral de prothèse totale de hanche en composite carbone-Peek.

This study concerns the fatigue behavior of a C/Peek hip implant. It is now well-established that the extent of bone loss around a total hip arthroplasty stem is related to stress shielding process. Due to a modulus mismatch between the bone and the implant material, the load transfer to the stem decreases the mechanical stimulus needed by the bone to maintain its structure. Because of its low modulus of elasticity and its good resistance to fatigue in aeronautical applications, the Fiber Carbon/Peek composite could potentially replace some of the metal alloys used in hip stem implant. After a literature survey on biomechanical performances of some fiber carbon composites, including AS4/Peek, experimental quasi-static and fatigue compression tests have been performed on AS4/Peek hip implants. The structural and mechanical characterization of the injection moulded composite material has been realized. The prosthesis compression and fatigue behaviour have been studied with a joint-stimulating apparatus immersed in a physiological solution temperature controlled. Instead of the low specimen homogeneity, no fatigue damage has been revealed either by X-ray observations of stiffness measurements, till ten millions of cycles. The quasi-static compressive fracture morphology has been analyzed by S.E.M. and have shown a good fiber matrix bonding. This mechanical results would suggest that AS4/Peek hip stem are worthy of further investigation as implantable prostheses.

Western blot monitoring of disseminated Nocardia nova infection treated with clarithromycin, imipenem, and surgical drainage.

A case of disseminated infection due to Nocardia nova with subcutaneous popliteal and retrosternal abscesses and lung involvement in an immunocompromised patient is reported. The patient did not respond to sulfonamide therapy. Clinical recovery was obtained upon treatment with imipenem then clarithromycin. Western blot studies revealed an antibody response to a known Nocardia-specific 55-kDa antigen in four successive sera samples collected in the period from the time of admission to seven months later. The resolution of the disseminated nocardiosis and efficacy of the clarithromycin treatment were assessed on the basis of disappearance of the antibodies to the 55-kDa antigen, without invasive sampling.

[Acetabular implant in Charnley's total arthroplasty. Review of 309 cases with a minimum of 15 years follow-up]. / L'implant cotyloïdien dans l'arthroplastie totale de Charnley. Revue de 309 dossiers avec un recul minimum de 15 ans.

PURPOSE OF THE STUDY: The aim of this study was to appreciate the long term result of 309 acetabular components of total hip arthroplasty. MATERIALS AND METHODS: All were performed using Charnley's prosthesis and cement, by one surgeon, between January 1972 and December 1975. Clinical function was graded according to Postel-Merle-d' Aubigné's scoring system (PMA score). We measured wear of polythylene using a personal method, on anteroposterior radiographs of the pelvis. Radiolucent line were appreciated by Delee and Charnley's criteria, migration by Massin's criteria. Survivorship curves were calculated with radiolucent lines, as migration, on 15 years. We compared the effect of different parameters on wear and loosening of the sockets. RESULTS: At 15 years follow-up, we found 51.5 per cent hips with the highest PMA score (18). Revision for socket loosening was 3.88 per cent, the same for dislocations. Concerning 25 per cent of the sockets, wear of polyethylene was evaluated less than 0.065 mm a year, concerning 50 per cent of them, it was evaluated less than 0.11 mm a year, at last concerning 75 per cent of them, it was evaluated less than 0.16 mm a year. No significant correlation was established between the tilt of the acetabular component and the wear of polyethylene. We observed no radiolucent lines for 60 per cent of the implants, nor migration for 83 per cent of them. Statistical analysis proved the influence of the wear on radiolucent lines and migration. DISCUSSION AND CONCLUSION: The analysis confirms a moderate wear of polyethylene during 15 years. We introduce an original method for its measurement and its formulation. This method allows a truly description of wear in long term results. This analysis confirms also that several parameters intercede on loosening; these are different if one considers radiolucent lines or migration. We do think at last, that the best positionning of the socket in the A.P. view should approach 35 degrees.

[Treatment of unstable fractures of the distal extremity of the radius by Hoffmann's external fixation. Report of 68 cases]. / Traitement des fractures instables de l'extrémité distale du radius par fixateur externe d'Hoffmann. A propos de 68 cas.

Sixty-eight fractures of the distal extremity of the radius, mostly unstable, homogeneously treated by Hoffmann's radio-metacarpal external fixation, were reviewed in terms of functional, objective and radiological criteria. Mean follow-up was 4 years, with a range of 6 months to 10 years. Overall, this treatment achieved 56% of satisfactory results, 26% moderate results and 18% poor results. Open and comminuted fractures give the worst overall results, mostly in terms of functional parameters. From this study, it is clear that external fixation is effective for the treatment of unstable fractures, as it provides good restitution of anatomical integrity of the radius, ensures better stabilization and allows immediate physiotherapy, leading to restoration of a good range of movement. Moreover, compliance with certain technical aspects such as minimal distraction, limits the disadvantages of this technique.

[Fractures of the humeral shaft: role of fasciculated nailing using Hackethal's method. Apropos of 129 cases]. / Fractures de la diaphyse humérale: place de l'embrochage fasciculé selon Hackethal. A propos de 129 cas.

This retrospective study was based on 141 diaphyseal fractures of the humerus, treated by Hackethal fasciculated pinning, among 371 fractures followed up during 10 years in our department. There were six preoperative radial paralyses. The mean consolidation delay was 65 days. Six fractures did not unite and there was no sepsis. The only immediate neurological postoperative complication was a regressive cubital paralysis. 72 fractures could be followed-up with a mean of 4 years, to establish a functional result chart. 94.4 per cent of the results were good and very good, 2 shoulder stiffness and only one elbow stiffness. The displaced fractures of the humeral diaphysis on D2 to D5 zones, as well as pathological fractures are good indications for Hackethal fasciculated pinning.

[Protocol for the use of Pavlik harness in the treatment of congenital dislocation and dysplasia of the hip]. / Protocole d'utilisation du harnais de Pavlik dans le traitement de la luxation congénitale et de la dysplasie de hanche.

The authors wanted to establish a protocol of use of Pavlik's harness and check ots efficiency with as few complications as possible for the ambulatory treatment of congenital dislocation and dysplasia of the hip. To achieve this, they studied 41 hips in 37 children. They noted 2 failures of reduction, 2 failures of stabilization, 2 cases of osteochondritis and 1 transitory crural paresis. It should be noted that reduction failed and osteochondritis and crural paresis occurred in one and the same child. The other children, ie. 36 hips, had a quite favorable evolution without any stay in hospital, and reduction and stabilization were permanent. This confirms the merits of Pavlik's harness and the low rate of iatrogenic complications. The authors propose a starting, observation and termination procedure for the treatment. However, it still is difficult to define how long stabilization will take and to specify the indication for the treatment of a possible residual dysplasia.