To assess variations in adherence to guidelines for management of postpartum hemorrhage (PPH) among midwives.
A multicentre vignette-based study was e-mailed to a random sample of midwives from 145 ...maternity units in France. They were asked to describe how they would manage the PPH described in 2 case-vignettes. These previously validated case-vignettes described 2 different scenarios for severe PPH. Vignette 1 described a typical immediate, severe PPH and vignette 2 a less typical case of severe but gradual PPH. They were constructed in 3 successive steps and included multiple-choice questions proposing several types of clinical practice options at each step. An expert consensus defined 14 criteria for assessing adherence to guidelines issued by the French College of Obstetricians and Gynecologists in 2004 in the midwives' responses. We analyzed the number of errors among the 14 criteria to quantify the level of adherence.
We obtained 450 complete responses from midwives from 87 maternity units. The rate of complete adherence (no error for any of the 14 criteria) was low: 25.1% in vignette 1 and 4.2% in vignette 2. The error rate was higher for pharmacological management, especially oxytocin use, than for non-pharmacological management and communication-monitoring-investigation. Adherence to guidelines varied substantially between and within maternity units, as well as between the vignettes for the same midwives.
Reponses to case-vignettes demonstrated substantial variations in PPH management and especially individual variations in adherence to guidelines. Midwives should participate in continuous and individualized training.
Summary
Background Lipoedema is an accumulation of fat abnormally distributed in the lower limbs, and lymphoedema is oedema caused by a deficiency of the lymphatic system. High‐resolution ultrasound ...operating at 20 MHz makes it possible to characterize dermal oedema.
Objectives The purpose of our study was to demonstrate that high‐resolution ultrasound imaging of the skin can differentiate lipoedema from lymphoedema.
Methods Sixteen patients with lymphoedema (22 legs), eight patients with lipoedema (16 legs) and eight controls (16 legs) were included. Patients with lipolymphoedema were excluded. Ultrasound examinations were carried out with a real‐time high‐resolution ultrasound device on three different sites for each lower limb. The images were then anonymized and examined by an independent dermatologist who was blind to the clinical diagnosis. A new series of images was examined by three dermatologists to check interobserver agreement.
Results A significant difference in dermal thickness was observed between patients with lymphoedema and those with lipoedema and between patients with lymphoedema and controls. No significant difference in dermal thickness was shown between patients with lipoedema and controls at the thigh or ankle. Dermal hypo‐echogenicity was found in at least one of the three sites in 100% of patients with lymphoedema, 12·5% of cases with lipoedema and 6·25% of the controls. Hypoechogenicity affected the entire dermis in all cases of lymphoedema except one. In cases of lipoedema and controls, hypoechogenicity was localized at the ankle and prevailed in the upper dermis. The expert correctly diagnosed all lower limbs with lymphoedema. No cases of lipoedema were diagnosed as lymphoedema. Exact interobserver agreement was excellent (0·98).
Conclusions High‐resolution cutaneous ultrasonography makes it possible to differentiate lymphoedema from lipoedema. Obtaining a reliable diagnosis through high‐resolution cutaneous ultrasonography might be valuable for improving the treatment of lipoedema and lymphoedema.
to identify staff and institutional factors associated with substandard care by midwives managing postpartum hemorrhage (PPH).
A multicenter vignette-based study was e-mailed to a random sample of ...midwives at 145 French maternity units that belonged to 15 randomly selected perinatal networks. Midwives were asked to describe how they would manage two case-vignettes about PPH and to complete a short questionnaire about their individual (e.g., age, experience, and full- vs. part-time practice) and institutional (private or public status and level of care) characteristics. These previously validated case-vignettes described two different scenarios: vignette 1, a typical immediate, severe PPH, and vignette 2, a severe but gradual hemorrhage. Experts consensually defined 14 criteria to judge adherence to guidelines. The number of errors (possible range: 0 to 14) for the 14 criteria quantified PPH guideline adherence, separately for each vignette.
450 midwives from 87 maternity units provided complete responses. Perfect adherence (no error for any of the 14 criteria) was low: 25.1% for vignette 1 and 4.2% for vignette 2. After multivariate analysis, midwives' age remained significantly associated with a greater risk of error in guideline adherence in both vignettes (IRR 1.19 1.09; 1.29 for vignette 1, and IRR 1.11 1.05; 1.18 for vignette 2), and the practice of mortality and morbidity reviews in the unit with a lower risk (IRR 0.80 0.64; 0.99, IRR 0.78 0.66; 0.93 respectively). Risk-taking scores (IRR 1.41 1.19; 1.67) and full-time practice (IRR 0.83 0.71; 0.97) were significantly associated with adherence only in vignette 1.
Both staff and institutional factors may be associated with substandard care in midwives' PPH management.
Little data are available regarding the rate and predicting factors of serious infections in patients with rheumatoid arthritis (RA) treated with abatacept (ABA) in daily practice. We therefore ...addressed this issue using real-life data from the Orencia and Rheumatoid Arthritis (ORA) registry.
ORA is an independent 5-year prospective registry promoted by the French Society of Rheumatology that includes patients with RA treated with ABA. At baseline, 3 months, 6 months and every 6 months or at disease relapse, during 5 years, standardised information is prospectively collected by trained clinical nurses. A serious infection was defined as an infection occurring during treatment with ABA or during the 3 months following withdrawal of ABA without any initiation of a new biologic and requiring hospitalisation and/or intravenous antibiotics and/or resulting in death.
Baseline characteristics and comorbidities: among the 976 patients included with a follow-up of at least 3 months (total follow-up of 1903 patient-years), 78 serious infections occurred in 69 patients (4.1/100 patient-years). Predicting factors of serious infections: on univariate analysis, an older age, history of previous serious or recurrent infections, diabetes and a lower number of previous anti-tumour necrosis factor were associated with a higher risk of serious infections. On multivariate analysis, only age (HR per 10-year increase 1.44, 95% CI 1.17 to 1.76, p=0.001) and history of previous serious or recurrent infections (HR 1.94, 95% CI 1.18 to 3.20, p=0.009) were significantly associated with a higher risk of serious infections.
In common practice, patients treated with ABA had more comorbidities than in clinical trials and serious infections were slightly more frequently observed. In the ORA registry, predictive risk factors of serious infections include age and history of serious infections.
Summary
Background Metastases of cutaneous melanoma may simulate benign blue naevi clinically.
Objectives To investigate the value of ultrasonography in the differential diagnosis of lesions that ...look similar clinically, i.e. blue naevi and cutaneous metastases of melanoma.
Methods Participants were invited for inclusion in the study if they had a cutaneous blue lesion clinically suggestive of a blue naevus or cutaneous metastasis of melanoma. After obtaining signed consent, the lesion was photographed and studied using dermoscopy and high‐resolution ultrasonography before being removed for histological examination. Clinical, dermoscopic and ultrasonographic images were reviewed anonymously by four dermatologists to assign the diagnosis of blue naevus or metastasis of melanoma. The diagnostic performance of clinical examination, dermoscopy and sonography was assessed for the ability of each to differentiate between metastases of melanoma and blue naevi with reference to the histological diagnosis. Moreover, experts undertook a semeiological description of each ultrasonographic image according to seven items: location of the lesion, echogenicity, homogeneity, shape of the lesion, definition of margins, posterior acoustic shadow and increased posterior echogenicity.
Results Twenty‐eight patients were included with a total of 39 blue skin lesions, and 17 of the 28 patients had a previous history of melanoma. Interobserver agreement in the semeiological description of the sonographic images was good (κ ≥ 0·6) for five of seven items. Sonography was more specific (94%) than clinical examination (77%) and dermoscopy (74%). The sonographic features contributing to the differential diagnosis were: location of the lesion (P = 0·027), shape of the lesion (P < 0·001), homogeneity (P = 0·001) and increased posterior echogenicity (P = 0·007).
Conclusions Ultrasonography is a reproducible and specific tool that can assist the differential diagnosis between blue naevi and metastases of melanoma. A blue naevus is a homogeneous, hypoechoic, ‘dish‐shaped’ lesion, located in the superficial dermis, whereas metastases of melanoma are ‘potato‐shaped’, hypoechoic, heterogeneous lesions, located in the hypodermis.
Among patients on long-term medical therapy, we compared (1) patient and physician assessments of drug adherence and of drug importance and (2) drug adherence reported by patients with drug ...importance as assessed by their physicians.
We recruited to the study patients receiving at least 1 long-term drug treatment from both hospital and ambulatory settings in France. We compared drug adherence reported by patients and drug importance assessed by physicians using Spearman correlation coefficients. Reasons for nonadherence were collected with open-ended questions and classified as intentional or unintentional.
Between April and August 2014, we recruited 128 patients taking 498 drugs. Patients and physicians showed only weak agreement in their assessments of drug adherence (r = -0.25; 95% CI, -0.37 to -0.11) and drug importance (r = 0.07; 95% CI, 0.00 to 0.13). We did not find any correlation between physician-assessed drug importance and patient-reported drug adherence (r = -0.04; 95% CI, -0.14 to 0.06). In all, 94 (18.9%) of the drugs that physicians considered important were not correctly taken by patients. Patients intentionally did not adhere to 26 (48.1%) of the drugs for which they reported reasons for nonadherence.
We found substantial discordance between patient and physician evaluations of drug adherence and drug importance. Nearly 20% of drugs considered important by physicians were not correctly taken by patients. These findings highlight the need for better patient-physician collaboration in drug treatment.
To investigate the effects on health-related quality of life (HRQOL) and functional capability of rituximab vs azathioprine for ANCA-associated vasculitis (AAV) maintenance therapy.
In a 24-month ...phase III randomised-controlled trial, 115 patients over time received rituximab or azathioprine for AAV maintenance therapy. Mean changes of 36-item Short-form Health Survey (SF-36) and Health Assessment Questionnaire (HAQ) scores from baseline were analysed.
Mean improvements of HAQ scores, from baseline to month 24 were significantly better for the rituximab (0.16 points lower) than the azathioprine group (p=0.038). As demonstrated by SF-36, study patients' baseline HRQOL was significantly impaired compared with age- and sex-matched US norms. At month 24, mean changes from baseline of SF-36 physical component score tended to be better for the rituximab group (+3.95 points, p=0.067) whereas mean changes from baseline of the SF-36 mental component score were significantly better for the azathioprine group (+4.23 points, p=0.041).
Azathioprine-treated patients' for AAV maintenance therapy showed a decline in physical abilities when compared to RTX at M24 in the MAINRITSAN trial.
ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00748644.
L’ESSDAI et l’ESSPRI, utilisés seuls, ne permettent pas d’evaluer tous les symptômes des patients atteints de syndrome de Sjögren primitif (SSp). Le consortium NECESSITY a tout recemment développé le ...Sjögren's Tool for Assessing Response (STAR), un indice composite comprenant 5 domaines couvrant tous les aspects de la maladie (activité systemique, PRO, atteinte salivaire et occulaire, biologiqie). Cet outil developpé par consensus (78 experts et 20 patients) a pour but d’etre utilisé comme critère principal d’evluation de la réponse au traitement dans les futurs essais cliniques. Les objectifs de cette etude etaient d’évaluer la réponse au STAR globale, en fonction de l’activité à l’inclusion, et dans chacun des 5 domaines, ainsi que d’évaluer la valeur ajoutée du score oculaire OSS, de l’échographie des glandes salivaires (SGUS) et du facteur rhumatoïde (FR) dans la cotation du STAR.
Cette étude s’appuie sur les 9 essais controlés randomisés utilisés pour le développement du STAR. L’OSS, la SGUS et le FR n’étant pas disponibles dans tous les essais, le concise STAR (cSTAR) a été calculé sans ces éléments à toutes les visites dans chaque essai. Un essai était considéré comme positif si une différence significative entre les deux bras était retrouvée pour au moins une visite. Des analyses stratifiées selon le clinESSDAI initial (<5 vs≥5) ont été réalisées chaque fois que possible. Le taux de réponse dans chaque domaine du STAR a été calculé, ainsi qu’un STAR le plus complet possible (STAR) incluant OSS, SGUS et FR lorsqu’ils étaient disponibles. La réponse SGUS a été définie comme une amélioration de 25 % du score disponible, car seul un essai a utilisé le score Hocevar. Les mêmes analyses ont été effectuées pour le Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS).
Le cSTAR et cCRESS ont classé de manière identique 6/9 trials. Les essais abatacept (ASAP-III), leflunomide+hydroxychloroquine (HCQ) et rituximab (RTX) (TEARS) ont été classés positifs par les 2 scores. Par contre, les essais HCQ (JOQUER) et RTX (TRACTISS) étaient classés positifs par le cCRESS uniquement et l’essai iscalimab par le cSTAR uniquement. Les analyses stratifiées selon l’activité basale ont montré une différence entre bras similaire pour chaque sous-groupe (clinESSDAI<or≥5) avec cSTAR. Pour le domaine systémique, la définition du CRESS (clinESSDAI final<5) classait comme répondeurs plus de patients avec un niveau d’activité intiale faible contrairement à la définition du STAR (diminution clinESSDAI≥3 points), a conduit à une augmentation du taux de réponse globale, notamment pour les traitements à activité biologique (RTX, HCQ), même en l’absence d’amelioration du clinESSDAI. Pour les patients avec activité modérée à élevée, un taux de réponse plus important a été observé avec le STAR, mais la différence entre bras similaire que chez les patients avec faible activité initiale. L’ajout du FR aux IgG dans le domaine biologique améliorait la différence entre les bras pour 3/5 essais. L’ajout de OSS n’apportait pas d’amélioration dans les 2 essais disponibles. L’ajout du score SGUS augmentait légèrement la différence entre bras dans les 3 essais disponibles.
Le cSTAR et cCRESS ont calssé de facon similaires pour la plupart des essais. Les différences observées sont liées à la définition de la réponse systémique ; CRESS classifie les patients avec activité faible comme répondeurs même en absence d’amélioration ESSDAI ou ESSPRI. L’ajout des FR et SGUS semble améliorer la réponse globale. Le STAR doit maintenant etre formellement validé dans l’essai prospectif NECESSITY avant de devenir le nouveau critère principal des essais au cours du SSp.
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