Influencia de la temperatura en la ingesta de pacientes hospitalizados.

BACKGROUND AND OBJECTIVES Prevalence of hyponutrition in hospitalized patients is very high and it has been shown to be an important prognostic factor. Most of admitted patients depend on hospital food to cover their nutritional demands being important to assess the factors influencing their intake, which may be modified in order to improve it and prevent the consequences of inadequate feeding. In previous works, it has been shown that one of the worst scored characteristics of dishes was the temperature. The aim of this study was to assess the influence of temperature on patient's satisfaction and amount eaten depending on whether the food was served in isothermal trolleys keeping proper food temperature or not. MATERIAL AND METHODS We carried out satisfaction surveys to hospitalized patients having regular diets, served with or without isothermal trolleys. The following data were gathered: age, gender, weight, number of visits, mobility, autonomy, amount of orally taken medication, intake of out-of-hospital foods, qualification of food temperature, presentation and smokiness, amount of food eaten, and reasons for not eating all the content of the tray. RESULTS Of the 363 surveys, 134 (37.96%) were done to patients with isothermal trays and 229 (62.04%) to patients without them. Sixty percent of the patients referred having eaten less than the normal amount within the last week, the most frequent reason being decreased appetite. During lunch and dinner, 69.3% and 67.7%, respectively, ate half or less of the tray content, the main reasons being as follows: lack of appetite (42% at lunch time and 40% at dinner), do not like the food (24.3 and 26.2%) or taste (15.3 and 16.8%). Other less common reasons were the odor, the amount of food, having nausea or vomiting, fatigue, and lack of autonomy. There were no significant differences in the amount eaten by gender, weight, number of visits, amount of medication, and level of physical activity. The food temperature was classified as adequate by 62% of the patients, the presentation by 95%, and smokiness by 85%. When comparing the patients served with or without isothermal trays, there were no differences with regards to baseline characteristics analyzed that might have had an influence on amount eaten. Ninety percent of the patients with isothermal trolley rated the food temperature as good, as compared with 57.2% of the patients with conventional trolley, the difference being statistically significant (P = 0.000). Besides, there were differences in the amount of food eaten between patients with and without isothermal trolley, so that 41% and 27.7% ate all the tray content, respectively, difference being statistically significant (P = 0.007). There were no differences in smokiness or presentation rating. CONCLUSIONS Most of the patients (60%) had decreased appetite during hospital admission. The percentage of hospitalized patients rating the food temperature as being good is higher among patients served with isothermal trolleys. The amount of food eaten by the patients served with isothermal trolleys is significantly higher that in those without them.

The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury

BACKGROUND Cerebral oedema is associated with significant neurological damage in patients with traumatic brain injury. Bradykinin is an inflammatory mediator that may contribute to cerebral oedema by increasing the permeability of the blood-brain barrier. We evaluated the safety and effectiveness of the non-peptide bradykinin B2 receptor antagonist Anatibant in the treatment of patients with traumatic brain injury. During the course of the trial, funding was withdrawn by the sponsor. METHODS Adults with traumatic brain injury and a Glasgow Coma Scale score of 12 or less, who had a CT scan showing an intracranial abnormality consistent with trauma, and were within eight hours of their injury were randomly allocated to low, medium or high dose Anatibant or to placebo. Outcomes were Serious Adverse Events (SAE), mortality 15 days following injury and in-hospital morbidity assessed by the Glasgow Coma Scale (GCS), the Disability Rating Scale (DRS) and a modified version of the Oxford Handicap Scale (HIREOS). RESULTS 228 patients out of a planned sample size of 400 patients were randomised. The risk of experiencing one or more SAEs was 26.4% (43/163) in the combined Anatibant treated group, compared to 19.3% (11/57) in the placebo group (relative risk = 1.37; 95% CI 0.76 to 2.46). All cause mortality in the Anatibant treated group was 19% and in the placebo group 15.8% (relative risk 1.20, 95% CI 0.61 to 2.36). The mean GCS at discharge was 12.48 in the Anatibant treated group and 13.0 in the placebo group. Mean DRS was 11.18 Anatibant versus 9.73 placebo, and mean HIREOS was 3.94 Anatibant versus 3.54 placebo. The differences between the mean levels for GCS, DRS and HIREOS in the Anatibant and placebo groups, when adjusted for baseline GCS, showed a non-significant trend for worse outcomes in all three measures. CONCLUSION This trial did not reach the planned sample size of 400 patients and consequently, the study power to detect an increase in the risk of serious adverse events was reduced. This trial provides no reliable evidence of benefit or harm and a larger trial would be needed to establish safety and effectiveness. TRIAL REGISTRATION This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN23625128.

Altered adaptive but not veridical decision-making in substance dependent individuals.

Drug addiction is associated with impaired judgment in unstructured situations in which success depends on self-regulation of behavior according to internal goals (adaptive decision-making). However most executive measures are aimed at assessing decision-making in structured scenarios, in which success is determined by external criteria inherent to the situation (veridical decision-making). The aim of this study was to examine the performance of Substance Abusers (SA, n = 97) and Healthy Comparison participants (HC, n = 81) in two behavioral tasks that mimic the uncertainty inherent in real-life decision-making: the Cognitive Bias Task (CB) and the Iowa Gambling Task (IGT) (administered only to SA). A related goal was to study the interdependence between performances on both tasks. We conducted univariate analyses of variance (ANOVAs) to contrast the decision-making performance of both groups; and used correlation analyses to study the relationship between both tasks. SA showed a marked context-independent decision-making strategy on the CB's adaptive condition, but no differences were found on the veridical conditions in a subsample of SA (n = 34) and HC (n = 22). A high percentage of SA (75%) also showed impaired performance on the IGT. Both tasks were only correlated when no impaired participants were selected. Results indicate that SA show abnormal decision-making performance in unstructured situations, but not in veridical situations.

Effect of iodine prophylaxis during pregnancy on neurocognitive development of children during the first two years of life.

CONTEXT The association between thyroid function during pregnancy and the later mental and psychomotor development of the child is supported by numerous experimental, clinical, and epidemiological studies. OBJECTIVE The aim of the study was to evaluate the psychological development of infants aged 3 to 18 months whose mothers had received 300 microg of potassium iodide during the first trimester of their pregnancy and compare with infants whose mothers had received no iodine supplements. DESIGN AND STUDY SUBJECTS: The study included 133 women who had received 300 microg of potassium iodine and 61 women who had received no iodine supplements. MAIN OUTCOME MEASURES The neuropsychological status of the children was evaluated with the Bayley Scales of Infant Development, and measurements were made of TSH, free T(3), free T(4), and urinary iodine. RESULTS Those children whose mothers had received an iodine supplement of 300 microg had a more favorable psychometric assessment than those of the other group of mothers. They had higher scores on the Psychomotor Development Index (P = 0.02) and the Behavior Rating Scale. CONCLUSIONS Dietary iodine supplements not only have no harmful effect on the neurodevelopment of the children, they may even be beneficial. Given the possible presence of confounding variables not controlled for in this study, these findings should be considered as preliminary.

Research letter: is neuroticism a risk factor for postpartum depression?

Although the relationship between personality and depressive illness is complex (Shea, 2005), there is empirical evidence that some personality features such as neuroticism, harm avoidance, introversion, dependency, self-criticism or perfectionism are related to depressive illness risk (Gunderson et al. 1999).

Valoración del nivel de satisfacción en un grupo de mujeres de Granada sobre atención al parto, acompañamiento y duración de la lactancia.

INTRODUCTION: The satisfaction's analysis is being used as an instrument to create different sanitary reforms to improve the quality and numerous studies aim to the increase the mother's satisfaction directly related to the maternity care. OBJECTIVES: [corrected] Identify the woman satisfaction's degree about birth attention, accompaniment during nativity and the breastfeeding's term. MATERIAL AND METHOD: [corrected] Descriptive transversal study in the university hospital San Cecilio in Granada (España), during the time of August 2011 to 2012, it performed with a second prospective tracing phase to a N = 60 mothers. It used a protocol (Annex 1) after 24 hours in hospital and at 14 days by telephone. After 3 months, it performed a tracing pertaining to the baby food. RESULTS: The global satisfaction's level about birth is high in study population. It has been shown that breastfeeding (P = 0,514) and vaginal birth without epidural (P = 0,320) creates higher satisfaction for mother. On the other hand, birth satisfaction related with duration of breastfeeding. CONCLUSION: Satisfactory mothers' opinion related with birth care and accompaniment during nativity increases in women whose birth happened in a uncomplicated way without epidural and they started early breastfeeding.

Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial.

Lisdexamfetamine dimesylate (LDX) is a long-acting, prodrug stimulant therapy for patients with attention-deficit/hyperactivity disorder (ADHD). This randomized placebo-controlled trial of an optimized daily dose of LDX (30, 50 or 70 mg) was conducted in children and adolescents (aged 6-17 years) with ADHD. To evaluate the efficacy of LDX throughout the day, symptoms and behaviors of ADHD were evaluated using an abbreviated version of the Conners' Parent Rating Scale-Revised (CPRS-R) at 1000, 1400 and 1800 hours following early morning dosing (0700 hours). Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference treatment, but the study was not designed to support a statistical comparison between LDX and OROS-MPH. The full analysis set comprised 317 patients (LDX, n = 104; placebo, n = 106; OROS-MPH, n = 107). At baseline, CPRS-R total scores were similar across treatment groups. At endpoint, differences (active treatment - placebo) in least squares (LS) mean change from baseline CPRS-R total scores were statistically significant (P < 0.001) throughout the day for LDX (effect sizes: 1000 hours, 1.42; 1400 hours, 1.41; 1800 hours, 1.30) and OROS-MPH (effect sizes: 1000 hours, 1.04; 1400 hours, 0.98; 1800 hours, 0.92). Differences in LS mean change from baseline to endpoint were statistically significant (P < 0.001) for both active treatments in all four subscales of the CPRS-R (ADHD index, oppositional, hyperactivity and cognitive). In conclusion, improvements relative to placebo in ADHD-related symptoms and behaviors in children and adolescents receiving a single morning dose of LDX or OROS-MPH were maintained throughout the day and were ongoing at the last measurement in the evening (1800 hours).

Artrodesis de tobillo: resultados comparativos de diferentes técnicas

INTRODUCTION: Ankle arthrodesis in an intervention that may be performed using a variety of surgical approaches. The joint may be stabilized using diferent systems, with or without bone graft. MATERIAL AND METHODS: Retrospective study that collected the results of 40 patients who underwent ankle arthrodesis; the complications that arose were analyzed, results according to the AOFAS clinical rating system, global patient satisfaction and the relationship with the articular approach route, the !xation system or the usage of grafts.RESULTS: 55% of the patients presented one or more complication that motivated a total of 12 re-interventions in 10 patients (excludes removal of osteosynthesis material). The absence of consolidation, which required a new arthrodesis was more frequent in patients where osteosynthesis was not used (two out of three cases) than in those using screws (four out of 24 cases), while there was no register of this in 13 patients in which intramedullary pin. The use of the distal extreme of the fibula or the iliac crest as bone graft has failed to improve the consolidation. Arthroscopic approaches avoid the appearance of soft tissue complications, although the consolidation disorders were more frequent. The average score on the AOFAS clinical rating system was 56.4±21.2 and 55% of the patients were satisfied. CONCLUSIONS: Although the case histories fail to provide significant results, it is a demanding intervention, with an elevated complication rate. Intramedullary pins seem to favor improved consolidation.

Suicidal ideation and the risk of suicide in patients with fibromyalgia: a comparison with non-pain controls and patients suffering from low-back pain.

Fibromyalgia is associated with an increased rate of mortality from suicide. In fact, this disease is associated with several characteristics that are linked to an increased risk of suicidal behaviors, such as being female and experiencing chronic pain, psychological distress, and sleep disturbances. However, the literature concerning suicidal behaviors and their risk factors in fibromyalgia is sparse. The objectives of the present study were to evaluate the prevalence of suicidal ideation and the risk of suicide in a sample of patients with fibromyalgia compared with a sample of healthy subjects and a sample of patients with chronic low-back pain. We also aimed to evaluate the relevance of pain intensity, depression, and sleep quality as variables related to suicidal ideation and risks. Logistic regression was applied to estimate the likelihood of suicidal ideation and the risk of suicide adjusted by age and sex. We also used two logistic regression models using age, sex, pain severity score, depression severity, sleep quality, and disease state as independent variables and using the control group as a reference. Forty-four patients with fibromyalgia, 32 patients with low-back pain, and 50 controls were included. Suicidal ideation, measured with item 9 of the Beck Depression Inventory, was almost absent among the controls and was low among patients with low-back pain; however, suicidal ideation was prominent among patients with fibromyalgia (P<0.0001). The risk of suicide, measured with the Plutchik Suicide Risk Scale, was also higher among patients with fibromyalgia than in patients with low-back pain or in controls (P<0.0001). The likelihood for suicidal ideation and the risk of suicide were higher among patients with fibromyalgia (odds ratios of 26.9 and 48.0, respectively) than in patients with low-back pain (odds ratios 4.6 and 4.7, respectively). Depression was the only factor associated with suicidal ideation or the risk of suicide.

A combination of ascorbic acid and α-tocopherol to test the effectiveness and safety in the fragile X syndrome: study protocol for a phase II, randomized, placebo-controlled trial.

BACKGROUND Fragile X syndrome (FXS) is an inherited neurodevelopmental condition characterised by behavioural, learning disabilities, physical and neurological symptoms. In addition, an important degree of comorbidity with autism is also present. Considered a rare disorder affecting both genders, it first becomes apparent during childhood with displays of language delay and behavioural symptoms.Main aim: To show whether the combination of 10 mg/kg/day of ascorbic acid (vitamin C) and 10 mg/kg/day of α-tocopherol (vitamin E) reduces FXS symptoms among male patients ages 6 to 18 years compared to placebo treatment, as measured on the standardized rating scales at baseline, and after 12 and 24 weeks of treatment.Secondary aims: To assess the safety of the treatment. To describe behavioural and cognitive changes revealed by the Developmental Behaviour Checklist Short Form (DBC-P24) and the Wechsler Intelligence Scale for Children-Revised. To describe metabolic changes revealed by blood analysis. To measure treatment impact at home and in an academic environment. METHODS/DESIGN A phase II randomized, double-blind pilot clinical trial. SCOPE male children and adolescents diagnosed with FXS, in accordance with a standardized molecular biology test, who met all the inclusion criteria and none of the exclusion criteria. INSTRUMENTATION clinical data, blood analysis, Wechsler Intelligence Scale for Children-Revised, Conners parent and teacher rating scale scores and the DBC-P24 results will be obtained at the baseline (t0). Follow up examinations will take place at 12 weeks (t1) and 24 weeks (t2) of treatment. DISCUSSION A limited number of clinical trials have been carried out on children with FXS, but more are necessary as current treatment possibilities are insufficient and often provoke side effects. In the present study, we sought to overcome possible methodological problems by conducting a phase II pilot study in order to calculate the relevant statistical parameters and determine the safety of the proposed treatment. The results will provide evidence to improve hyperactivity control and reduce behavioural and learning problems using ascorbic acid (vitamin C) and α-tocopherol (vitamin E). The study protocol was approved by the Regional Government Committee for Clinical Trials in Andalusia and the Spanish agency for drugs and health products. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01329770 (29 March 2011).

Patients' and physicians' preferences for type 2 diabetes mellitus treatments in Spain and Portugal: a discrete choice experiment.

OBJECTIVE To assess Spanish and Portuguese patients' and physicians' preferences regarding type 2 diabetes mellitus (T2DM) treatments and the monthly willingness to pay (WTP) to gain benefits or avoid side effects. METHODS An observational, multicenter, exploratory study focused on routine clinical practice in Spain and Portugal. Physicians were recruited from multiple hospitals and outpatient clinics, while patients were recruited from eleven centers operating in the public health care system in different autonomous communities in Spain and Portugal. Preferences were measured via a discrete choice experiment by rating multiple T2DM medication attributes. Data were analyzed using the conditional logit model. RESULTS Three-hundred and thirty (n=330) patients (49.7% female; mean age 62.4 [SD: 10.3] years, mean T2DM duration 13.9 [8.2] years, mean body mass index 32.5 [6.8] kg/m(2), 41.8% received oral + injected medication, 40.3% received oral, and 17.6% injected treatments) and 221 physicians from Spain and Portugal (62% female; mean age 41.9 [SD: 10.5] years, 33.5% endocrinologists, 66.5% primary-care doctors) participated. Patients valued avoiding a gain in bodyweight of 3 kg/6 months (WTP: €68.14 [95% confidence interval: 54.55-85.08]) the most, followed by avoiding one hypoglycemic event/month (WTP: €54.80 [23.29-82.26]). Physicians valued avoiding one hypoglycemia/week (WTP: €287.18 [95% confidence interval: 160.31-1,387.21]) the most, followed by avoiding a 3 kg/6 months gain in bodyweight and decreasing cardiovascular risk (WTP: €166.87 [88.63-843.09] and €154.30 [98.13-434.19], respectively). Physicians and patients were willing to pay €125.92 (73.30-622.75) and €24.28 (18.41-30.31), respectively, to avoid a 1% increase in glycated hemoglobin, and €143.30 (73.39-543.62) and €42.74 (23.89-61.77) to avoid nausea. CONCLUSION Both patients and physicians in Spain and Portugal are willing to pay for the health benefits associated with improved diabetes treatment, the most important being to avoid hypoglycemia and gaining weight. Decreased cardiovascular risk and weight reduction became the third most valued attributes for physicians and patients, respectively.