Local hyperhemia to heating is impaired in secondary Raynaud's phenomenon

Accurate and sensitive measurement techniques are a key issue in the quantification of the microvascular and endothelial dysfunction in systemic sclerosis (SSc). Thermal hyperhemia comprises two separate mechanisms: an initial peak that is axon reflex mediated; and a sustained plateau phase that is nitric oxide dependent. The main objective of our study was to test whether thermal hyperhemia in patients with SSc differed from that in patients with primary Raynaud's phenomenon (RP) and healthy controls. In a first study, we enrolled 20 patients suffering from SSc, 20 patients with primary RP and 20 healthy volunteers. All subjects were in a fasting state. Post-occlusive hyperhemia, 0.4 mg sublingual nitroglycerin challenge and thermal hyperhemia were performed using laser Doppler flowmetry on the distal pad of the third left finger. In a second study, thermal hyperhemia was performed in 10 patients with rheumatoid arthritis and 10 patients with primary RP. The thermal hyperhemia was dramatically altered in terms of amplitude and kinetics in patients with SSc. Whereas 19 healthy volunteers and 18 patients with primary RP exhibited the classic response, including an initial peak within the first 10 minutes followed by a nadir and a second peak, this occurred only in four of the SSc patients (p < 0.0001). The 10 minutes thermal peak was 43.4 (23.2 to 63), 42.6 (31 to 80.7) and 27 (14.7 to 51.4) mV/mm Hg in the healthy volunteers, primary RP and SSc groups, respectively (p = 0.01), while the 44°C thermal peak was 43.1 (21.3 to 62.1), 42.6 (31.6 to 74.3) and 25.4 (15 to 52.4) mV/mm Hg, respectively (p = 0.01). Thermal hyperhemia was more sensitive and specific than post-occlusive hyperhemia for differentiating SSc from primary RP. In patients with rheumatoid arthritis, thermal hyperhemia was also altered in terms of amplitude. Thermal hyperhemia is dramatically altered in patients with secondary RP in comparison with subjects with primary RP. Further studies are required to determine the mechanisms of this altered response, and whether it may provide additional information in a clinical setting

Mécanismes de l'altération de l'hyperhémie thermique dans la sclérodermie systémique

Le but est de comprendre les mécanismes de l'altération de l'hyperhémie thermique couplée au laser Doppler dans la sclérodermie systémique (SSc). Première étude : l'altération de l'hyperhémie thermique n'est localisée que sur le doigt chez 21 sclérodermiques, y compris chez ceux sans fibrose cutanée, par rapport à 21 sujets avec un phénomène de Raynaud primaire et 21 volontaires sains. La fibrose cutanée n'intervient pas dans cette réponse anormale. Deuxième étude : nous avons corrélé les anomalies de l'hyperhémie thermique et la pression artérielle systolique digitale au repos et à 44C chez 39 sclérodermiques. La pression systolique digitale ne chute pas à 44 C alors que des patients ont une réponse anormale. Une macroangiopathie n'intervient pas dans cette réponse anormale. L'hyperhémie thermique est altérée dans la SSc spécifiquement au niveau digital. La fibrose cutanée et une macroangiopathie n'expliquent cette altération ainsi une microangiopathie explique cette réponse anormale.The objective was to determine why thermal hyperemia is impaired in patients with systemic sclerosis (SSc) using laser Doppler flowmetry.In the first study, we compared the thermal hyperemia on finger and on forearm in SSc patients, in comparison with primary Raynaud's phenomenon and healthy volunteers. Thermal hyperemia was impaired only on finger in SSc patients. In SSc patients without cutaneous fibrosis, the response was altered too. In the second study, we tested whether the altered thermal hyperemia correlated to the digital pressure index at baseline and following the thermal challenge. In SSc patients tested at 44C, the digital systolic blood pressure index was the same at baseline and at 44C, while 7 of them had an abnormal response in terms of kinetic. In SSc patients, digital thermal hyperemia is impaired, but does not relate to the skin fibrosis or to an macroangiopathy. We have to determine whether its impairment reflects functional or structural microvascular damage.GRENOBLE1-BU Médecine pharm. (385162101) / SudocPARIS-BIUM (751062103) / SudocSudocFranceF

[Evolution of the satisfaction of subjects enrolled in clinical studies]

Within the context of a quality initiative for a clinical research unit, participants' opinions relative to participation conditions allows the identification and quantification of certain dysfunctions in the unit or more widely of the site. An initial satisfaction survey of users of the Grenoble Clinical Research Center showed that the management of volunteers by a staff dedicated to, and in an environment adapted to, clinical research protocols is associated with elevated participant satisfaction. Corrective action has been taken relative to points of dissatisfaction. We conducted a second participant survey from June 1st, 2004, to May 31st, 2005, to measure the impact of our corrective actions. Eighty five percent of the persons contacted responded, and 90.4% of completed questionnaires were valid. The global satisfaction level on a scale of ten was 8.53 +/- 1.16 in 2005 (n = 292) versus 8.61 +/- 1.16 in 2004 (n = 144) (Not Significant = NS). Scores for each dimension of care (comprising 1-6 questions each) were not statistically different between the two years. An improvement was noted for the frequency of physician visits, the communication of results, and the explication of aftercare. On the other hand, there was a moderate decline of the satisfaction score relative to concern for personal needs, the swiftness of check in at arrival and the unit's peace and quiet. Globally, the participation of a subject in clinical research in the context of a Clinical Research Center is associated with a high satisfaction score. Nevertheless, the practice of annual satisfaction surveys permits the sensitisation of staff to certain specifics points, and to observe the effect of corrective action. It serves as an important element in the context of a quality initiative

[Evolution of the satisfaction of subjects enrolled in clinical studies]

Within the context of a quality initiative for a clinical research unit, participants' opinions relative to participation conditions allows the identification and quantification of certain dysfunctions in the unit or more widely of the site. An initial satisfaction survey of users of the Grenoble Clinical Research Center showed that the management of volunteers by a staff dedicated to, and in an environment adapted to, clinical research protocols is associated with elevated participant satisfaction. Corrective action has been taken relative to points of dissatisfaction. We conducted a second participant survey from June 1st, 2004, to May 31st, 2005, to measure the impact of our corrective actions. Eighty five percent of the persons contacted responded, and 90.4% of completed questionnaires were valid. The global satisfaction level on a scale of ten was 8.53 +/- 1.16 in 2005 (n = 292) versus 8.61 +/- 1.16 in 2004 (n = 144) (Not Significant = NS). Scores for each dimension of care (comprising 1-6 questions each) were not statistically different between the two years. An improvement was noted for the frequency of physician visits, the communication of results, and the explication of aftercare. On the other hand, there was a moderate decline of the satisfaction score relative to concern for personal needs, the swiftness of check in at arrival and the unit's peace and quiet. Globally, the participation of a subject in clinical research in the context of a Clinical Research Center is associated with a high satisfaction score. Nevertheless, the practice of annual satisfaction surveys permits the sensitisation of staff to certain specifics points, and to observe the effect of corrective action. It serves as an important element in the context of a quality initiative

Évolution de la satisfaction des usagers du CIC de Grenoble

Dans le cadre de la démarche qualité d'une unité de recherche clinique, l'avis des participants quant aux conditions de participation permet de soulever et quantifier certains dysfonctionnements de l'unité ou plus largement du site. Une première enquête de satisfaction des usagers du Centre d'Investigation Clinique (CIC) de Grenoble avait montré que la prise en charge des sujets par du personnel spécifique et dans un lieu adapté, dans le cadre de protocoles de recherche clinique, était associée à une satisfaction élevée des participants. Des mesures correctives avaient été mises en place concernant les points négatifs. Nous avons réalisé une seconde enquête pour les participants inclus entre le 1$^{\text{er}}$ juin 2004 et le 31 mai 2005, afin de mesurer l'impact des mesures mises en œuvre. Quatre-vingt cinq pour cent des personnes contactées ont répondu à notre enquête et 90,4 % de ces questionnaires étaient exploitables. Le score global, côté sur 10, était de 8,53 ±1,16 en 2005 (n = 292) versus 8,61 ± 1,16 en 2004 (n = 144) [Non Significatif = NS]. Les scores calculés pour les différentes dimensions de soin n'étaient pas non plus statistiquement différents entre les deux années. Une amélioration a été notée pour la fréquence des visites des médecins, la communication des résultats et l'explication du suivi médical. Par contre, une baisse modérée du score de satisfaction concernant le souci des besoins personnels, la rapidité de prise en charge à l'arrivée et le calme du service a été mise en évidence. Globalement, la participation d'un sujet à une recherche biomédicale dans le cadre d'un CIC est associée à un taux de satisfaction élevée. Cependant, la pratique d'enquêtes de satisfaction annuelles permet de sensibiliser le personnel sur certains points spécifiques et d'observer l'effet de la mise en œuvre de mesures correctrices. Elle se révèle un élément important dans le cadre d'une démarche qualité