ABSTRACT
INTRODUCTION: Evaluating the benefits and risks of prolonged hormonal treatment with aromatase inhibitors (AIs) for treating hormone-dependent breast cancer. METHODS: A systematic review and meta-analysis was conducted. Studies reporting on randomized clinical trials concerning prolongating hormonal therapy with AIs as compared to a placebo or no prolongation, after an initial five years of hormonal therapy, were eligible. RESULTS: Seven clinical trials were included. Prolonged AI therapy was associated with a statistically significant improvement in disease-free survival (RR=0.70, 95% CI 0.60 to 0.80). A statistically significant increase was observed for osteoporosis (RR=1.17, 95% CI 1.03 to 1.33), hot flushes/flashes (RR=1.27, 95% CI 1.08 to 1.49), myalgia (RR=1.23, 95% CI 1.09 to 1.39), fractures (RR=1.26, 95% CI 1.09 to 1.45) and arthralgia (RR=1.17, 95% CI 1.10 to 1.25). However, no statistically significant association was observed between prolonged AI therapy and overall survival, cardiovascular events, and bone pain. DISCUSSION: Prolonged AI therapy has significant benefits in terms of disease-free survival in women with hormone-dependent breast cancer. However, adverse effects and a lack of evidence for a benefit on overall survival must be considered in the decision-making process regarding adjuvant hormone therapy extension.
Subject(s)
Breast Neoplasms , Female , Humans , Breast Neoplasms/drug therapy , Aromatase Inhibitors/adverse effects , Combined Modality Therapy , Chemotherapy, Adjuvant/adverse effects , Adjuvants, Immunologic/therapeutic use , Hormones/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Tamoxifen/adverse effectsABSTRACT
Resumo O Ensaio Clínico Aleatorizado (ECA) é considerado o tipo de desenho metodológico com maior poder de verificação da eficácia das psicoterapias. Entretanto, especialmente a partir da segunda metade do século XX, muitas críticas direcionadas às concepções epistemológicas subjacentes às ditas "ciências duras" atingiram também, no âmbito das ciências da saúde, os estudos que adotavam esse desenho. Este artigo é uma reflexão crítica sobre algumas das objeções feitas aos ECAs, avaliando de que maneira e até que ponto estes poderiam se configurar como estratégia válida de investigação científica no contexto crítico apontado. Conclui-se que o ECA pode e deve ser utilizado - desde que em contexto crítico - por seu valor pragmático, enquanto produtor de predições e intervenções capazes de solucionar problemas clínicos, inevitavelmente definidos e estabelecidos a partir do ponto de vista particular de uma comunidade.
Abstract The randomized controlled clinical trial (RCT) is considered the type of methodological design with the greatest power to verify the efficacy of psychotherapies. However, especially from the second half of the twentieth century, many criticisms directed at the epistemological conceptions underlying the so-called "hard sciences" have also affected the studies that adopted this design. This article is a critical reflection on some of the objections made to randomized clinical trials, evaluating how and to what extent these trials could be configured as a valid scientific research strategy in this critical context. We concluded that the RCT should be used - as long as it is performed in a critical context - due to its pragmatic value, as a producer of predictions and interventions capable of solving clinical problems, inevitably defined and established from the particular point of view of a community.
Résumé L'essai clinique randomisé est considéré comme le type de conception méthodologique ayant le plus puissant pour vérifier l'efficacité des psychothérapies. Cependant, surtout depuis la seconde moitié du XXe siècle, de nombreuses critiques adressées aux conceptions épistémologiques qui sous-tendent les sciences dites « dures ¼ ont également affecté, dans le cadre des sciences de la santé, les études qui ont adopté cette conception. Cet article est une réflexion critique sur certaines des objections faites aux essais cliniques randomisés, évaluant comment et dans quelle mesure ceux-ci pourraient être configurés comme une stratégie valide de recherche scientifique dans le contexte critique signalé. On en conclu que l'ECA peut et doit être utilisé - à condition que ce soit dans un contexte critique - pour sa valeur pragmatique, en tant que producteur de prédictions et d'interventions capables de résoudre des problèmes cliniques, inévitablement définies et établies du point de vue particulier d'une communauté.
Resumen El ensayo clínico aleatorizado (ECA) se considera el tipo de diseño metodológico con mayor poder para verificar la eficacia de las psicoterapias. Sin embargo, especialmente desde la segunda mitad del siglo XX, muchas críticas dirigidas a las concepciones epistemológicas subyacentes a las llamadas "ciencias duras" también han afectado, dentro del alcance de las ciencias de la salud, los estudios que adoptan este diseño. Este artículo es una reflexión crítica sobre algunas de las objeciones hechas a los ECA, evaluando cómo y en qué medida podrían configurarse como una estrategia de investigación científica válida en este contexto crítico. Se concluye que el ECA puede y debe usarse, siempre y cuando se encuentre en un contexto crítico, por su valor pragmático como productor de predicciones e intervenciones capaces de resolver los problemas clínicos inevitablemente definidos y establecidos desde el punto de vista particular de una comunidade.
Subject(s)
Psychotherapy/methods , Behaviorism , Efficacy , Knowledge , Evidence-Based Practice , JudgmentABSTRACT
OBJECTIVE: The effect of any sterilization methods (cold chemical, or hot) on film removal from coated archwires has not yet been investigated. Thus, we assessed it. MATERIALS AND METHODS: This double-blind randomized clinical trial was performed on 120 observations: 40 macroscopically intact coated archwires from 4 brands were purchased (n=10 archwires/brand). Five wires from each brand underwent cold and 5 underwent hot sterilization. Wires were applied in 40 non-extractions patients at alignment phase of treatment (one month). Afterwards, 3 inter-bracket segments from each wire were examined microscopically, and the percentage of coating loss was recorded for each segment. Coating losses of the 4 brands and 2 sterilization methods were compared using a two-way ANOVA and a Welch t-test (α=0.05). Surfaces were also evaluated using scanning electron microscopy. RESULTS: The mean surface coating loss of hot (autoclave) and cold (glutaraldehyde) sterilization methods was 25.6±28.7 and 28.1±30.8 percent respectively. The mean surface coating removal of the Ortho Organizers, American Orthodontics, SIA, and Gestenco brands were 24.1±28.4, 36.7±36.0, 23.0±24.4, and 23.6±28.0 percent, respectively. The two-way ANOVA indicated a lack of overall significant differences among wire brands (P=0.189) and between sterilization types (P=0.629). However, the interaction of sterilization and brands was significant (P=0.005). CONCLUSIONS: Within the limitations of this 1-month clinical trial limited to 4 coated NiTi archwire brands only, the average coating removal of examined brands might not differ much, amounting to about 26% within a month. Glutaraldehyde and autoclave sterilization might not affect the average speed of coating loss in all brands, although each sterilization method might be favourable for certain brands.
Subject(s)
Glutaral/pharmacology , Orthodontic Wires , Sterilization/methods , Double-Blind Method , Esthetics, Dental , HumansABSTRACT
OBJECTIVES: To evaluate the clinical outcomes and costs of managing pneumonia and severe malnutrition in a day clinic (DC) management model (outpatient) vs. hospital care (inpatient). METHODS: Randomised clinical trial where children aged 2 months to 5 years with pneumonia and severe malnutrition were randomly allocated to DC or inpatient hospital care. We used block randomisation of variable length from 8 to 20 and produced computer-generated random numbers that were assigned to one of the two interventions. Successful management was defined as resolution of clinical signs of pneumonia and being discharged from the model of care (DC or hospital) without need for referral to a hospital (DC), or referral to another hospital. All the children in both DC and hospital received intramuscular ceftriaxone, daily nutrition support and micronutrients. RESULTS: Four hundred and seventy children were randomly assigned to either DC or hospital care. Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (0.65-0.97), P = 0.02]. During 6 months of follow-up, 30/235 (12.8%) in the DC group and 36/235 (15.3%) required readmission to hospital in the hospital care group [RR (95% CI) = 0.89 (0.67-1.18), P = 0.21]. The average overall healthcare and societal cost was 34% lower in DC (US$ 188 ± 11.7) than in hospital (US$ 285 ± 13.6) (P < 0.001), and costs for households were 33% lower. CONCLUSIONS: There was a 7% greater probability of successful management of pneumonia and severe malnutrition when inpatient hospital care rather than the outpatient day clinic care was the initial method of care. However, where timely referral mechanisms were in place, 94% of children with pneumonia and severe malnutrition were successfully managed initially in a day clinic, and costs were substantially lower than with hospital admission.
OBJECTIFS: Evaluer les résultats cliniques et les coûts de la prise en charge de la pneumonie et de la malnutrition sévère dans un modèle de prise en charge en clinique de jour (CJ) (patients ambulatoires) par rapport à des soins hospitaliers (patients hospitalisés). MÉTHODES: Essai clinique randomisé où les enfants âgés de 2 mois à 5 ans avec une pneumonie et une malnutrition sévère ont été répartis de façon aléatoire en CJ ou à des soins hospitaliers. Nous avons utilisé la randomisation par blocs de longueur variable de 8 à 20 et avons généré des nombres aléatoires par ordinateur qui ont été attribués à l'une des deux interventions. Une prise en charge réussie a été définie comme la résolution des signes cliniques de pneumonie et la sortie du modèle de soins (CJ ou hospitalisation) sans nécessiter un transfert à un hôpital (CJ), ni à un autre hôpital. Tous les enfants du bras CJ et du bras soins hospitaliers ont reçu de la ceftriaxone par voie intramusculaire, un soutien nutritionnel quotidien et des micronutriments. RÉSULTATS: 470 enfants ont été assignés aléatoirement soit à des soins en CJ ou hospitaliers. Une prise en charge réussie a été obtenue pour 184 patients sur 235 (78,3%) en CJ seule contre 201 sur 235 (85,5%) en soins hospitaliers [RR (IC95%) = 0,79 (0,65 - 0,97), p = 0,02]. Au cours des six mois de suivi, 30/235 (12,8%) du groupe CJ et 36/235 (15,3%) du groupe soins hospitaliers ont nécessité une réadmission à l'hôpital [RR (IC95%) = 0,89 (0,67 - 1,18), p = 0,21]. Le coût moyen global des soins de santé et pour la société était de 34% plus faible dans le groupe CJ (188 ± 11,7 USD) que dans le groupe soins hospitaliers (285 ± 13,6 USD) (p < 0,001) et les coûts pour les ménages étaient de 33% inférieurs. CONCLUSIONS: La probabilité d'une prise en charge réussie de la pneumonie et de la malnutrition sévère était 7% plus élevée lorsque les soins hospitaliers plutôt que les soins en CJ étaient les moyens initiaux. Cependant, là où des mécanismes de référence rapides étaient en place, 94% des enfants atteints de pneumonie et de malnutrition sévère ont été pris en charge avec succès dans une clinique de jour et les coûts étaient nettement inférieurs à ceux de soins hospitaliers.
Subject(s)
Ambulatory Care Facilities/economics , Ambulatory Care/economics , Child Nutrition Disorders/economics , Child Nutrition Disorders/therapy , Hospitalization/economics , Pneumonia/economics , Pneumonia/therapy , Ambulatory Care/statistics & numerical data , Ambulatory Care Facilities/statistics & numerical data , Child, Preschool , Female , Health Care Costs/statistics & numerical data , Hospitalization/statistics & numerical data , Humans , Infant , Inpatients/statistics & numerical data , Male , Treatment OutcomeABSTRACT
Red blood cell units are stored up to 42 days post-collection. The standard policy of blood banks is to deliver the oldest units in order to limit blood wastage. Many caregivers believe that giving fresh rather than old units can improve the outcome of their transfused patients. The ABLE study aims to check if the transfusion of red blood cell units stored seven days or less (fresh arm) improve the outcome of transfused critically ill adults compared to patients who received units delivered according to the standard delivery policy (control arm). From March 2009 to May 2014, 1211 patients were allocated to the fresh arm, 1219 to the control arm (length of storage: 6.1 ± 4.9 and 22.0 ± 8.4 days respectively, P<0.001). The primary outcome measure was 90-day all-cause mortality post-randomisation: there were 448 deaths (37.0%) in the fresh arm and 430 (35.3%) in the control arm (absolute risk difference: 1.7%; 95% confidence interval: -2.1% to 5.5%). In a survival analysis, the risk of death was higher in the fresh arm (hazard ratio: 1.1; 95%CI: 0.9 to 1.2), but the difference was not statistically significant (P=0.38). The same trend against the fresh arm was observed with all but one secondary outcome measures. The conclusion is that the transfusion of red blood cell units stored seven days or less does not improve the outcome of critically ill adults compared to the transfusion of units stored about three weeks (22.0 ± 8.4 days).
Subject(s)
Blood Preservation/methods , Critical Illness/therapy , Erythrocyte Aging , Erythrocyte Transfusion , Adult , Canada/epidemiology , Critical Care/methods , Critical Illness/mortality , Diagnosis-Related Groups , Europe/epidemiology , Female , Hospital Mortality , Humans , Male , Time Factors , Treatment OutcomeABSTRACT
Diabetic macular edema (DME) is a frequent complication of diabetic retinopathy and may cause severe visual loss. In this article, we examine the pathophysiology of DME and review various treatment options, such as laser photocoagulation, anti-vascular endothelial growth factor (VEGF) receptor antibodies, and steroids including ILUVIEN(®), which is a new sustained-release, non biodegradable, injectable, intravitreal micro-implant containing fluocinolone acetonide. The results of the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) studies, conducted to evaluate the efficacy and safety of ILUVIEN(®) in DME, are discussed.
